chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 61 year old female patient with chronic hepatic failure, rosuvastatin hypersensitivity and blueberries hypersensitivity. It was reported that the patient was on the list for liver transplant. On 31-JUL-2017, the patient was vaccinated with VARIVAX lot # N012132 for prophylaxis and other suspect therapies included STERILE DILUENT. Concomitant therapies included calcium carbonate, ceftriaxone, folic acid, lactobacillus unspecified, lactulose, vitamins (unspecified), omeprazole and thiamine. On 15-AUG-2017, the patient experienced rash all over her body (disseminated varicella zoster vaccine virus infection). Later on 16-AUG-2017, she was admitted to the hospital for an unspecified reason (adverse event) and was prescribed with acyclovir and valacyclovir hydrochloride. Thereafter, on 22-AUG-2017, the physician sent samples from the rash to the CDC for typing on 22-AUG-2017, and on the same date, diagnosed the patient with "disseminated disease". The reporting physician mentioned that lab confirmed "samples of the patient's rash were the vaccine strain of varicella" on 06-SEP-2017. At the time of the report, the patient recovered of disseminated varicella zoster vaccine virus infection on an unspecified date in 2017. However, she continued hospitalized due to "unspecified medical reasons". Upon internal review, the event disseminated varicella zoster vaccine virus infection was considered to be medically significant. The causal relationship between disseminated varicella zoster vaccine virus infection, adverse event and VARIVAX and STERILE DILUENT was not provided. The reporting physician requested a lot check for VARIVAX lot # N012132. This is one of two reports received from the same source. Sender's Comments: US-009507513-1709USA004101.
This is a spontaneous report from a contactable consumer (medical assistant) via a Pfizer sales representative. A female patient of an unspecified age received PREVNAR 13, (lot number and expiration date unknown) via an unspecified route of administration on 26May2018 at single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she had a rash under both arms, fever of 100.5 degrees, fatigue, chills, and weakness. The reporter stated that the symptoms lasted for 36 hours, but she is unsure if the patient has recovered completely. The outcome of rash under both arms, fever of 100.5 degrees, fatigue, chills, and weakness was unknown. The following information on the batch number has been requested.
Patient experienced swelling, redness, and discomfort in a 2-3 inch radius oblong area on her left arm surrounding the injection site.  The area was inflammed and she stated it was sensitive to the touch.
Moderna COVID-19 Vaccine EUA About 5 minutes after I received the vaccine, my throat started to get scratchy.  About another 10 minutes or so later, I had tongue and slight lip tingling.  Because they thought I may have a reaction, they sent me to the ED.  But I never developed any facial or throat swelling and never had an anaphylactic reaction.  After about 24 hours the tingling went away.
The patient reports right calf pain 5 days after vaccination, followed by palpitations and dyspnea for the past two week.  She presented to the ER today, June 12 2021, and was found to have a right calf DVT as well as multiple bilateral pulmonary emboli.  Her ER visit today also shows newly diagnosed metastatic lesions in the liver and a colonic mass.  It is not clear if any of the thromboembolic disease is secondary to the Covid vaccine at all, or all related to the new metastatic disease.  Decision was made to report this event due to her reported timing of symptoms and patient request to report as well.  She is being transferred to Medical Center for hospitalization and treatment.
This vaccine is not intended for infants.  It was given mistakenly.   Family reported swelling at administration site, fussiness, low grade temperature to 99.1, then fatigue and decreased PO intake.  The fatigue and decreased PO intake lasted a week.  Note that he also received rota and Pentacel that day.  All of these symptoms could have been related, or entirely unrelated to the HPV vaccine administration, or anywhere in between.  Tough to tell.
patient was given expired IPOL vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00567208) and transmitted to Sanofi on 19-Apr-2021.  This case involves a 4-years-old male patient who received an expired 0.5 mL fourth dose of IPV (VERO) [IPOL] vaccine (batch number: R1B25 and expiry date: 13-Mar-2021) via an intramuscular route in right thigh for prophylactic vaccination on 12-Apr-2021 (expired product administered).  Medical history, past medical treatment and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and CHICKENPOX for prophylactic vaccination.  No other vaccines were received by patient.  It was an actual medication error case due to expired vaccine used (latency: same day).  The reporter wanted to know what to do if 8 patients got expired IPOL vaccine.  At the time of reporting, 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.
3 days of an aching back & neck muscles, twitching leg muscles, diarrhea and sleepiness.  Treated with tylenol, Contact flu tablets.
Itchy Throat, burning, headache, elevated BP Given Benadryl, Famotidine IV and observed.  Symptoms resolved in about 45mins.  Patient discharged.
This case was reported in a literature article and described the occurrence of acute meningoencephalitis in a 28-year-old female subject who was vaccinated with DTPa (with small D + P) (manufacturer unspecified) and Seasonal trivalent Influenza vaccine. On an unspecified date, the subject received an unspecified dose of DTPa (with small D + P) (administration site and route unknown, batch number not provided) and an unspecified dose of Seasonal trivalent Influenza vaccine (administration site and route unknown, batch number not provided). 5 days after vaccination with DTPa (with small D + P), 10 days after vaccination with Seasonal trivalent Influenza vaccine, the subject experienced nausea, vomiting and headache. The subject was hospitalised with photophobia, progressive weakness, acute change in mental status, confusion, expressive aphasia, neck pain and stiffness. The final diagnosis was acute meningoencephalitis with encephalopathy. At the time of reporting, the events were resolved. This is one of the 11 cases created from the same literature article. Summary of the literature article: Pre-licensure clinical trials for two licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). To characterize reported AEs following Tdap vaccination and identify potential safety concerns warranting further evaluation, we analyzed data from the Vaccine Adverse Event Reporting System (VAERS) and assessed the frequency and proportions of AEs and reporting rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The majority of reports described common local and systemic signs and symptoms, such as injection site reactions, fever, and headache. Rarely reported AEs included myopericarditis, demyelinating diseases of the central nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis, seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion stated that because adolescents and adults were not routinely vaccinated against pertussis in the past, this surveillance summary provides important - and reassuring - information about the use of Tdap in these age groups. Although subject to the limitations of passive surveillance, the findings of this VAERS review support the pre-licensure clinical trial data with regard to the safety of the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that are temporally associated with Tdap vaccination and further assessment of such events using controlled observational studies may provide additional information about the safety of these vaccines.
flulike symptoms; bad night; nausea; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever). On 19-Mar-2021, INFLUENZA LIKE ILLNESS (flulike symptoms), INSOMNIA (bad night), NAUSEA (nausea), VOMITING (vomiting) and PYREXIA (fever) had resolved.            No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
Vaccine administration error: Patient stated they had not received a previous dose of any covid vaccine and was administered a full dose (0.5ml) instead of the half dose(0.25ml) for the third dose in the series. Vaccine was given at proper interval for booster dose >6 months after 2nd dose which was given on (04/21/21). At time of follow-up(11/23/21) patient reported normal side effects (fevers, chills, aches) that started approximately 8 hours post vaccination and had not fully resolved at that time.
I did not experience any side effects from my first Pfizer dose.  Approximately 12 hours after the vaccine (second dose), I developed mild flu-like symptoms and  I ran a low grade (99.7F) fever.  During the time I had a fever, I developed a low-level, high pitch ringing in both my ears.  By the next morning, the flu-like symptoms and fever were gone, but the tinnitus remained.  After two months, I still have ringing in both years.  Though I still consider the volume low level, it has gotten more noticeable over time.
had the flu vaccine 2 hours later in hospital 5 hours later life support; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 hrs after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hospitalization (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter's friend granddaughter had the flu vaccine 2 hours later in hospital 5 hours later life support for 3 weeks million dollars hospital bill and at the time of reporting had other problems.
After injected yellow fever vaccine to patient, patient felt fainting and looked very pale. Patient then became unconscious for seconds. Called 911. While waiting for paramedic, pt slowly regained consciousness. Paramedic arrived and measure his blood pressure. The result was normal. Patient denied to go to hospital.
Moderna COVID-19 Vaccine EUA  General headache beginning at 1630, transitioning to migraine level by 2200. Low level head ache next day, following with joint pain, muscle and body aches, and fatigue
Patient received 1st dose of a two dose series of pediatric covid pfizer vaccine. Patient felt anxious and upset stomach 5 minutes receiving the vaccine. Patient felt better after sitting down for a few minutes and was followed up later at the emergency room
Recieved phone call from clients mother at 10:30 this morning.  Mother stated that child had recieved flu shot at flu clinic on 10/29/08.  Later that evening she noted red hives developing, she did not give her anything at that time but in the morning she was red all over and had all over.  Mother has been giving patient Benadryl about every 5 hours and she did go to school today.  States maybe she didn't need any Benadryl but I did give her some before she went to school.  Mother had spoke with friends of hers about the reaction and they advised her to keep giving the Benadryl until syptoms had gone away and that she needed to let us know this so a report could be completed.  This is the first time patient had recieved the flu vaccination and does not have any allergies to eggs.
Pt was vaccinated on 5/18/13. History of RA and on MTX. MTX dosing is 25mg per week. Wt of pt = 170 lbs. During the week of 5/26 the patient saw red bumps (several) near the injection site. As of 5/31 she still has the bumps. The bumps do not hurt or itch.
No adverse event; Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients had been administered with the Moderna vaccine (more or less 170 monovalent) which were beyond the 30 days beyond use date).    No concomitant medication was reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 monovalent and 20 bivalent) which were beyond the 30 days beyond use date.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up received; Patient information and vaccinations details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Itching; Redness; Swelling; Lymphadenopathy; A spontaneous report was received from a nurse concerning two patients of an unknown age and gender who received Moderna's COVID-19 Vaccine (mRNA-1273 ) and who experienced redness, swelling, itching and lymphadenopathy.   The patient's medical history was not provided. No relevant concomitant medications were not provided.  On an unknown date, prior to onset of the events, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced delayed local reactions to Moderna COVID-19 vaccine including redness, swelling, itching and lymphadenopathy. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events redness, swelling, itching and lymphadenopathy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program. A patient (no qualifiers provided) received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had COVID-19 (in less than 24 hours, tested positive for Omnicron), with outcome of unknown. Relevant laboratory tests and procedures available in the appropriate section. The lot number for BNT162B2 not provided and will be requested during follow-up.
BIPOLAR DISORDER; ATTENTION DEFICIT HYPERACTIVITY DISORDER; SPOT ON LEG; PAIN ALL OVER; POST-TRAUMATIC STRESS DISORDER; This spontaneous report received from a consumer concerned a female of unspecified age, unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Medical history and other relevant history was not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1143998 expiry: UNKNOWN), 1 total, dose and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date, the patient experienced bipolar disorder, attention deficit hyperactivity disorder, spot on leg, pain all over, and post-traumatic stress disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the attention deficit hyperactivity disorder, spot on leg, pain all over, bipolar disorder and post-traumatic stress disorder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210937232-covid-19 vaccine ad26.cov2.s-bipolar disorder. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
SORE ARM FOR 30 MINUTES; KNEES ACHED; This spontaneous report received from a patient via a company representative concerned a 75 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm for 30 minutes, and knees ached. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm for 30 minutes, and the outcome of knees ached was not reported. This report was non-serious.
Late entry:  Vaccine reaction on 1/11/21.  Reaction for 1st does , syncope at work and vomited. 2nd vaccine-Dizziness and lightheadedness. No other symptoms. Vital Signs stable.  monitored, discharged - with ride to pick up.
Feb 13-22 racing heart and irregular heart beat for 10 days.  Feb 23, 7:30-10:30 am, woke feeling jittery with steady racing heart and irregular heart beat.  Red, slightly raised welt (2.5" x 1.5") appeared at injections site.   Called PCP and was advised to go to ER
9 days after the shot I got a 2 inch round red area that developed.  It is sore to the touch and warm to the touch .  It does not itch
adverse events: left eye became itchy, leading to skin around the under side of the to become slightly raw from rubbing. within 24 hrs. of the eye becoming itchy, my eye became more irritated and slowly became painful to blink. Within about 4 days, it was too painful to bare and ended up going to the ER, followed by seeing a cornea specialist. The cornea specialist noted several filaments skin from the eye) that were scattered around my, which she ended up removing (about 7 pieces i believe). She was not quite sure what it was and eventually went to go see a cornea specialist at Medical Hospital (near where i live/work). No specific diagnosis was given except possibly being herpetic, but even then the specialist didn't think that was the cause.
Information has been received from a health professional concerning a 75 year old female who on 10/25/95 and 10/18/01 was vaccinated with a 1st and 2nd dose of pneumococcal vaccine 23 polyvalent. On 10/18/01, a few hours, post vax, the pt returned with a reaction that was described as a very swollen injection site that was as hard as a rock. The pt was dx'd with cellulitis and on 10/18/01, she was put on treatment with oral cephalexin and prednisone. The pt was seen in the office on 10/20/01 and was doing better. The pt was seen 3 more times, the last on 10/27/01 and had fully recovered. The reporter noted that the practice had been administering the vaccine for years and they have never had a problem. Upon internal review, the pt's cellulitis was considered to be an "Other Important Medical Event". Additional information has been requested. F/U states: It was also noted that another pt who was vaccinated from the same lot developed a similar events (WAES01103264). The reporter stated that she and another nurse are now concerned and afraid to use the rest of the lot. The reporter stated that she was grateful that a check would be done on this lot and reported that their practice would not administer any more of the (pneumococcal vaccine 23 polyvalent) until they received information on the results of the lot check. The records of testing prior to release of this lot have been checked by CMP Compliane and found to be satisfactory. This lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information from the health professional noted that the physician wanted to exchange this lot for a new lot number. Upon internal review, the pt's cellulitis was considered to be an other important medical event. No further info is available.