chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was scheduled to receive a tdap, administering nurse gave him another meningococcal vaccine, which is confirmed to be MENQUADFI with no reported adverse event; menquadfi dose administered too early given 8 months apart with no reported adverse event; Initial information received on 12-Jul-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 12 years old male patient who was scheduled to receive a tdap, administering nurse gave him another meningococcal vaccine, which is confirmed to be meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event and menquadfi dose administered too early given 8 months apart with no reported adverse event.  The patient's past vaccination(s) included meningococcal vaccine on 17-Nov-2022. The patient's past medical history, medical treatment(s) and family history were not provided.  On 11-Jul-2023, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (batch number: U7633AB) (expiry date unknown) via intramuscular route in the left deltoid for immunization while he was scheduled to receive a tdap and dose administered too early given 8 months apart with no reported adverse event (wrong product administered) (inappropriate schedule of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 the guidelines. 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.
Covid 19 + 08/26/2021 with onset 08/25/2021
mom states fingers turned blue, became numb/tingling (not rest of arm; arm sore); MD gave ATB; ATB for ears;
I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; I got the shot and came home ever thing was fine then arm started hurting no big deal then thr headache so bad I had tears in 58. Carpet installer most of my life now that all happened Tuesday felt si; Tuesday felt sick; itching; Crazy itchy once I itch it swells up; I'm broke out all over my arm. And face; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported) via an unspecified route of administration, at arm left on 22Mar2021 12:00 as single dose for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history included high blood pressure. The patient had no allergies to medications, food, or other products. The patient received antibiotics within 2 weeks of vaccination. The patient concomitant medications were not reported. The patient got the shot and came home ever thing was fine then arm started hurting no big deal then the headache so bad I had tears. Carpet installer most of my life now that all happened Tuesday felt sick, we and things seemed instill till about the 26th started itching bad and it got worse and broke out all over my arm and face. Crazy itchy once I itch it swells up. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient states had sudden onset of severe pain, in bilateral legs - right shin and left foot and ankle pain. Lasted 15 minutes, then gradually went away. Fine this AM.
Headache, Myalgia, Fatigue, Hot Flashes, Chills Narrative:
Numbness and pain in left hand, left forearm, left shoulder blade and left side of chest. Numbness of face and ears. Pain in back, hip and heel. Took steroids for treatment and it gave temporary reliefe. Took pain relievers as well with no effect.
Patient was sitting in observation and after 5 mins patient began c/o itching of neck. Upon exam patient exhibited urtacaria of neck and chest. Patient denied any difficulty breathing or shortness of breath. LS:CTAx4, VS: 132/68, RR:16, HR:92, SPO2: 99% on room air. Patient was given Benadryl 50mg IM in Left Deltoid. Patient was reassesed at 5 mins post benadryl administration with relief of itching and urtacaria still present. Patient still denied difficulty breathing. @ 10 mins patient had complete relief of symptoms. Patient stayed additional 10 mins w/o incident. Patient instructed to follow up with physician or call 9-1-1 in case of emergency.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 14.25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 11-FEB-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Generalized maculopapular rash to trunk with upper extremities. Very itchy starting 1-2 after vaccine. No fever. No fatigue. No vesicles.
By 9:00pm, pt reports redness, pain, swelling and heat at site of injection site. Within 24 hrs, the area around the injection site had swollen to approx. 4" X 4 1/2", with a raised welt along one edge of the swelling.
cut to the hand; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient cut his/her hand on an unspecified date with outcome of unknown. The patient received tetanus shot on 07Jan2021, for cut to the hand on an unspecified date. He was due to get 2nd dose of COVID vaccine tomorrow and queried if the patient can receive 2nd dose.  Information on Lot/Batch has been requested.
BODILY ACHES, FUZZY HEAD (more than usual) FLU LIKE SYMPTOMS (no upset stomach)  .  I TOOK  TYLENOL , DRANK FLUIDS AND SLEPT
Severe headache and tremors, high fever of 103.2, weakness to point of not being able to stand alone.
Child would not eat and fever started per mother child would not eat until next day when we had her come in to be checked out because the mother stated she had not eaten in over 12 hours and fevers hadn't broken.
Patient has sensitive skin. Stated she noticed it a couple weeks after the shot. She is not sure if from shingrix shot. Taking precaution by filling form out. She recently has also had reaction from bug bite possibly (she thinks) on other arm where shot was not given and had reaction on legs (looks like razor burn). Leg reaction likely due to being in yard working and skin sensitive so broke out in reaction (contact dermatitis). Patient not sure if reaction on right shoulder is from shingrix. If so possible reaction at site of injection from the shot, bumps in a round pattern. Patient trying hydrocortisone and benadryl to bring inflammation down. Does not itch she stated.
This spontaneous report was received from a medical assistant (Healthcare worker) regarding an approximately 2 month old female patient. The pertinent medical history and drug reactions or allergies were reported as none. On 08-APR-2014, the patient was vaccinated with first dose of ROTATEQ, product lot # J008739, expiration date: 25-MAR-2015, dose 2 ml (milliliter) orally as routine vaccination, the second dose of ROTAEQ, product lot# J013625, expiration date:  31-MAR-2015, dose 2 ml orally was received on 10-JUN-2014 and on 12-AUG-2014, the third dose of ROTATEQ, product lot # K003524, Expiration date: 29-JAN-2016, dose 2 ml orally was received. On an unknown date in 2014, the patient developed a circular black spot on the top and bottom of her tongue sometime before the third dose was given. On 18-AUG-2014, the patient was in physician's office because the spot had got worse. No treatment was given, at this time they were monitoring her and ruling things out. No intervention was done to prevent serous criteria. It was reported as unknown whether the adverse event was cancer. There was no product quality complaint involved. The outcome of the event was unknown. The causality was unknown. Additional information has been requested.
Severe fatigue and headache; body aches and sensitivity; mild nausea; possible light fever  Events started 6 hours after administration, began clearing overnight after full day of symptoms  Generic brand NyQuil was taken both nights of symptoms due to acetaminaphin content.  Ibuprofin pills were taken to ease headache before it was understood to be a vaccine reaction.  The ibuprofin did not seem to have an effect.
Information has been received from a physician concerning a 16 year old female who on 14-OCT-1994 was vaccinated with the first dose of MMR II HSA (lot# not provided). On 01-JUL-1997 the patient received the second dose of MMR II HSA (lot# not provided) . On 19-DEC-2009 the patient developed mumps (date diagnosed 16-NOV-2009). Patient did not develop fever and had parotitis. Blood work on 16-NOV-2009 was negative. IgG 5.46, serum amylase 317. Patient' outcome was unknown. Follow up information has been received from a physician who reported that the 17 year old patient (also reported as a 16 year old at onset date) experienced mumps on 17-JAN-2010 (previously reported as 19-DEC-2009). This date diagnosed was reported as 18-JAN-2010 (previously reported as 16-NOV-2009). It was reported that the patient had left parotitis, swelling on left (side neck) and no other symptoms. On 18-JAN-2010, blood work was performed, results were: IgM <1:10, IgG 8.71 and serum amylase 75. It was unknown if the patient was exposed to others with mumps (sibling or classmate). At the time of the report the patient's outcome was unknown. This is one of several reports from the same source. No further information is available.
This spontaneous report as received from a consumer referring to himself as a 69 year old male patient with hypertension and not known drug reactions or allergies. Approximately in 2010, about four or five years ago, the patient was vaccinated with ZOSTAVAX, 1 injection (dose, route of administration and lot number not provided). Concomitant medication included unspecified blood pressure medication. On 12-MAY-2014, the patient experienced herpes zoster located at the T-10 vertebra causing a bulge and herpes zoster rash on his right buttocks. The patient reported that the pain was so bad that he was like a slithering snake, unable to cough, sneeze or clear his throat he also felt like being jabbered with an electric probe. On an unspecified date, the patient sought for medical attention and had a magnetic resonance imaging (MRI) and an X-ray done (results for both of them were not provided); he was also treated with ibuprofen, acupuncture, massages and oxycodone. Regarding the bulge on the T-10 vertebra, the patient recovered on an unknown date; and regarding the event of herpes zoster the patient reported he was feeling a 90 percent better at the time of reporting. Additional information has been requested.
Patient received a flu vaccine for the first time 10/17/2019. Patient has had residual pain in the arm that received the vaccination. Described pain as sharp in the elbow and bicep as well as weakness especially with movement.   Went to the doctor Dec. 6th  as pain was not getting better.  She has taken ibuprofen  but it was not helpful.    She has not had any tests or referrals at this time but will be following up with the doctor.
Felt fatigue and chills all day. It felt like the onset of the flu.   Reporting this only for data collection. Felt fine the next day.
developed shingles on day two following vaccine.  Area involved includes left chest, underarm, left upper arm and upper back areas.
C/O anxious & nervous.  "did not want to be touch" "I'm with my older sister & will go home with them.
whole arm rash itching like crazy; slight fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (whole arm rash itching like crazy), PYREXIA (slight fever) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (whole arm rash itching like crazy), PYREXIA (slight fever) and FATIGUE (fatigue). At the time of the report, RASH PRURITIC (whole arm rash itching like crazy), PYREXIA (slight fever) and FATIGUE (fatigue) outcome was unknown.     Concomitant medication use was unknown.  Patient  went to his doctor and got a cream for the rash.   This case was linked to MOD-2021-368796, MOD-2021-368777 (Patient Link).
Systemic: Fainting / Unresponsive-Medium, Systemic: See statement below-Medium, Additional Details: Minor patient with parents in attendance. After receiving immunization, patient stood up, took a few steps and fainted, falling backward and hitting head on the floor. Pharmacy staff immediately called 911 and provided supportive first aid. Patient quickly regained consciousness, RPh had her continue to lay in the floor, provided pillow for head, elevated feet and ice pack was applied to back of head. Paramedics arrived to evaluate patient's condition, patient was released home with parents.
reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time; One of the medical assistants reported excursion on 14Feb2023 previously.; Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (reported excursion on 14Feb2023 previously. Now they are following up to see if the 6 doses administered to children during this time), PRODUCT TEMPERATURE EXCURSION ISSUE (One of the medical assistants reported excursion on 14Feb2023 previously.), PRODUCT STORAGE ERROR (Maximum temperature: -1.8 C Storage at time of excursion: freezer Excursion duration: unknown for each day starting on 01Feb2023 and continued until 14Feb2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-712044 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2023: Follow-up received contains additional no new information was updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712044:
On 01-07-2021 and about 12 hours later I started to feel ill, had muscle aches, shivers, fever of 100 degrees. I also had a nasty headache with a sore throat for about 36 hours. I took Acetaminophen and Ibuprofen and rested in bed. On the second day my symptoms started to improve and the rash I had at the injection site on my left arm started to get smaller and started to improve in appearance.
This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored ROTATEQ orally, (reported lot # as: M023169 with expiration date: 13-JUN-2018 and L037554 with expiration date: 25-DEC-2017 and L037554 with expiration date: 25-DEC-2017). However, dosage number and route of administration were not reported, for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 60 hours between 32 grades Fahrenheit and 36 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested.
pt recvd vax in 1993 & pt had no detectable antibodies; No further details were provided;
This study case was received from the investigator on 02 March 2011. A 20-year-old male subject with a medical history significant for headaches was vaccinated with ACAM2000 on 24 March 2010 (lot number not reported). Concomitant vaccines consisted of TYPHIM Vi on 24 March 2010 (lot numbers not reported). On 07 April 2010, 14 days post vaccination, the subject was diagnosed with unspecified disease of pericardium. An ECG performed on 24 May 2010 was normal; Troponin I results were not available. No other information was provided. The outcome of the subject was not reported. List of documents held by sender: None. Note: Additional information will be requested from the investigator. There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.
at 1335 pt received 2nd dose of pfizer vaccine and brought to observation area for 30mins to monitor by me, escorted by staff, pt already feeling dizzy & hands tingling & heart racing. place in triage chair, vitals measured, assessed, alert and oriented x 3, responds appropriately, clear bilateral equal lung sounds, mild distress with her feeling dizzy asking to lay down on a bed. ask another staff to grab gurney nearby as pt said her dizziness getting worse and eyelids appeared heavier and almost falling off chair while being observed, rapid response called at 1345. pt now on gurney laying supine, Several Vaccine clinic staff assisted me along with Rapid response team, vitals rechecked again at 1350, pt c/o of worsening dizziness and 5/10 headache with hands still tingling, heart still racing. After rapid response team evaluated pt, at 1352 plan to bring pt to ER for further evaluation.
that night i got up about 12:00 AM my face was swollen, red, eyes was red and sowllen , and felt sick all over. Call doctor in  morning to let him know what was going on. Nurse said the it was a side effect and should going away. Call back on wed. becasue my face was still red and swollen go was still not felling good. Nurse said that it could go on for 3 to 6 day. If still not doing good call back  on Friday.
urticaria, hives; Erythema, redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) and VACCINATION SITE SWELLING (Swelling) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE URTICARIA (urticaria, hives), VACCINATION SITE ERYTHEMA (Erythema, redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Initial report received on 22 November 2006 from an investigator participating in the above-mentioned trial. A 72-year-old female subject with history of Crohn's disease was diagnosed with exacerbation of Crohn's disease, 9 days after she had received a first dose, right arm, intramuscular injection of Influenza Virus Vaccine USP Trival A & B, High dose, Subvirion-U, lot number not reported, on 25 October 2006. Her medical history also included: osteoarthritis, glaucoma, vascular headaches, vasomotor rhinitis, labile blood pressure, asthma, nephrolithiasis, hyperglycemia, gastroesophageal reflux and dyspepsia, cholecystectomy. Concomitant treatments were Combivent, Advair, Prilosec, Potassium, timolol. On 27 November 2006, two days post-vaccination, the subject experienced diarrhea and nausea that lasted 9 days, until 06 November 2006. On 03 November 2006 the subject experienced hypokalemia that lasted a day, until 04 November 2006. The subject was admitted to the hospital on 03 November 2006 and discharged on 06 November 2006. The subject was treated with Prednisone 40 mg daily, mesalamine 1200mg 4 times a day and IV fluids with potassium chloride. The subject had recovered. Important laboratories results done at the hospital: C-Diff toxin-negative; feces culture- no E.coli or salmonella; stool for WBC's-negative; chemistry panel-normal, Hemogram + PLT + Autodif + WBC-High; Lactate-normal. The subject continued in the study trial. According to the investigator, the event was related to the study vaccine. Documents held by sender: hospital admission and discharge summaries and laboratory results.