chrisvoncsefalvay/vaers-outcomes huggingface dataset:
when the Imovax was injected the needle hit her bone with no reported adverse event with no reported adverse event; Initial information received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves an unknown age female patient to whom, when the RABIES (HDC) VACCINE [IMOVAX RABIES] was injected the needle hit her bone with no reported adverse event.  The patient's past medical history included Animal bite. The patient's past medical treatment included RABEGARD. The patient's past vaccination(s) included IMOVAX. The patient's past family history was not provided.  Concomitant medications included ARIPIPRAZOLE (ABILIFY) for White blood cell count increased.  On an unknown date, the patient received a dose of suspect RABIES (HDC) VACCINE (formulation, dose, strength, lot number: unknown) via unknown route in unknown administration site as Immunization.  On an unknown date the patient developed a non-serious event "when the imovax was injected the needle hit her bone with no reported adverse event (wrong technique in product usage process) (latency: same day) following the administration of RABIES (HDC) VACCINE.  It was reported "Caller reports when Imovax was mixed it was foaming and she questions whether she got the whole dose".  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
2 hours after injection patient broke out in hives-beginning at injection site and spreading over entire body, pruritic. Seen in Urgent Care-documented as urticaria by MD-responded to BENADRYL, ZYRTEC-No SOB, no difficulty swallowing or other signs of symptoms.
Numbness in fingers, pain in the joints sometimes and spots on hands and arms, dizziness.
A non-serious spontaneous report of half dose of H1N1 administered to a 15-month-old child was received from a registered nurse/health professional concerning a 15-month-old female. The patient's medical history was not provided. On 10-Nov-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
Location were shot was administered is a pain of 7 out of 10. Loss of taste/smell/aches.
No additional AE reported; Gardasil 9 that had undergone temperature excursion on 12/10/2021 was administered to a patient on 1/10/2022; This spontaneous report was received from a medical assistant and refers to a 17-year-old male patient. His pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.   On 12-DEC-2021, the product HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (lot number 1687291 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 11-SEP-2022) experienced a temperature excursion reported as: 23 degrees Fahrenheit (F) during a time frame of 2 and a half (reported as "2 and 1/2") seconds. No previous temperature excursion reported.  On 10-JAN-2022, the patient was vaccinated with an improperly store dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (ml) (vaccination scheme frequency, route of administration and anatomical site of application were not reported) (product storage error) as prophylaxis.  No additional adverse event (AE) was reported (no adverse event).
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Two weeks after first COVID vaccine patient experienced an acute onset of chest pain, dizziness, head pressure, SOB, fast/irregular heart rate, high blood pressure, sensitivity to light, weakness and blackening of vision field.
Reaction had a diameter of 6 inches and went up her shoulder; Tingling into her fingers; itchy/Itchiness; Patient has hardness and a red circle around the injection site, itchiness and tingling into her fingers. She states that her arm was sore, extremely painful and itchy; Arm was sore/Extremely Painful; Hardness and a red circle around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Reaction had a diameter of 6 inches and went up her shoulder), PARAESTHESIA (Tingling into her fingers), VACCINATION SITE PRURITUS (itchy/Itchiness), VACCINATION SITE INDURATION (Patient has hardness and a red circle around the injection site, itchiness and tingling into her fingers. She states that her arm was sore, extremely painful and itchy) and VACCINATION SITE PAIN (Arm was sore/Extremely Painful) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Reaction had a diameter of 6 inches and went up her shoulder), PARAESTHESIA (Tingling into her fingers), VACCINATION SITE PRURITUS (itchy/Itchiness), VACCINATION SITE INDURATION (Patient has hardness and a red circle around the injection site, itchiness and tingling into her fingers. She states that her arm was sore, extremely painful and itchy), VACCINATION SITE PAIN (Arm was sore/Extremely Painful) and VACCINATION SITE ERYTHEMA (Hardness and a red circle around the injection site). At the time of the report, ADVERSE REACTION (Reaction had a diameter of 6 inches and went up her shoulder), PARAESTHESIA (Tingling into her fingers), VACCINATION SITE PRURITUS (itchy/Itchiness), VACCINATION SITE INDURATION (Patient has hardness and a red circle around the injection site, itchiness and tingling into her fingers. She states that her arm was sore, extremely painful and itchy), VACCINATION SITE PAIN (Arm was sore/Extremely Painful) and VACCINATION SITE ERYTHEMA (Hardness and a red circle around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Injection site reactions of a sore arm; circumference of the shot was bigger than when she first got the injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection). At the time of the report, INJECTION SITE PAIN (Injection site reactions of a sore arm) and VACCINATION SITE SWELLING (circumference of the shot was bigger than when she first got the injection) outcome was unknown. Not Provided          Products known to have been used by the patient, within two weeks prior to the event, included type 1 diabetes medication. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Patient reported that patient, did not get any adverse event after the first dose, and was undergoing colonoscopy on 21 Apr 2021.
This case was reported by a healthcare professional and described the occurrence of infantile spitting up in a 4-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included PENTACEL (Sanofi Pasteur MSD) and PREVNAR 13 (Wyeth Labs) both given on 27 September 2011. There were no concurrent medications. On 27 September 2011 at 10:30 the subject received 1st dose of ROTARIX (oral). On 27 September 2011, less than one day after vaccination with ROTARIX, the subject experienced infantile spitting up. It was reported that the baby spit up everything that his mother fed him and according to the mother, the child has never spit up. At the time of reporting the outcome of the event was unspecified.
Devel arthritis involving knee 12/97.  Was treated and well until vax. Post vax, pt exp pain in knee without swelling and continues to do so. Per follow-up: Patient received vaccine in 11/99. Within one week, he experienced recurrence of knee pain accompanied by minimal swelling in his left knee. He had a history of L knee arthritis from 12/97 s/p amoxicillin.
FEVER, CONGESTION/RUNNY NOSE, SORE THOAT, SOB, , COUGH, WEAKNESS, COVID EXPOSURE
ecked her platelets and they had dropped from 80 in September to 15; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOCYTOPENIA (ecked her platelets and they had dropped from 80 in September to 15) outcome was unknown.            Concomitant medications were not reported .  Company Comment: This case concerns a 93-year-old, female patient, with medical history of immunocompromised state, who experienced the serious, unexpected, AESI event of thrombocytopenia. The event occurred  on unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable as patient received treatment (prednisone) for event. The patient's immunocompromised state remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395476, MOD-2021-392157 (Patient Link).; Sender's Comments: This case concerns a 93-year-old, female patient, with medical history of immunocompromised state, who experienced the serious, unexpected, AESI event of thrombocytopenia. The event occurred  on unknown date after the first dose of mRNA 1273 vaccine. The rechallenge is not applicable as patient received treatment (prednisone) for event. The patient's immunocompromised state remains as a confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Patient was in the office for his 18 month WCV and a new nurse accidently highlighted the PCV on the Vaccine from. The provider did order this and the orders and vaccines were double checked by preceptor. Extra dose of PCV 13 was given. No reaction in office. Provider did call MOC who was informed.
Information has been received from a physician who received a "health alert" from the state health department concerning a 16 week old patient who was vaccinated with unspecified PEDVAXHIB (manufacturer unknown) (Lot# not reported). Shortly after receiving the unspecified PEDVAXHIB (manufacturer unknown) the patient developed HIB. The outcome of adverse events was unknown. It was not reported whether the patients sought medical attention. This is one of several reports received from the same resource. Follow-up information was received from the Health Alert Coordinator who stated that she had received the faxed request from Merck for the Health Alert sheet dated on 09-MAR-2009. She stated that she had given the request to the registered nurse, regional nurse manager. The case involved a 16 week old male with an onset of February 24th. Diagnoses included apnea, sepsis, and bilateral pneumonia. Health history included premature delivery at 24 weeks gestation and bronchopulmonary dysplasia. H. influenzae was isolated from blood with serogroup b. The infant had received the recommended first dose of HIB containing vaccine at 2 months of age. Upon internal review apnea was determined to be an other important medical event. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PATIENT SAYS RASH IS TRAVELING UP ARM AND IS NOW AT NECK. WILL UPDATE US IF GETS WORSE
Patient reported "Burning from inside out". Pain when pressure has put against skin. No rash, but some "pimples" reported on chest, some flaking of skin. Patient prescribed Gabapentin and condition improved (300mg tid).
Dizziness for 48+ hours.  Feeling of hypersensitive skin to touch
member reports joint pains in several joints (hands, feet, knees, back) that have persisted since the time of original vaccine administration. by now it's been about 7 months since symptom onset.
About 25 hours after receiving the flu vaccine, patient developed hives at the injection site. Mom gave Zyrtec. Hives started to clear the following day and resolved within 48 hours.
Pt recvd vax 22JUL92 & devel a white depigmented spot a couple of days following the vax; depigmented areas also appeared on the inner side of both arms & above elbows;
Total loss of hearing in right ear.  Sudden on set.  Went to bed fine.  Woke up total deaf in right ear.
J96.00 ACUTE RESPIRATORY FAILURE 6/23/2021 ASTHMA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 6/11/2021 ASTHMA, UNSPECIFIED
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored M-M-R II (incorrect product storage) (lot numbers: L001336, Expiry date: 13-JAN-2017; lot numbers: L012482, Expiry date: 10-APR-2017; lot numbers: K021952, Expiry date: 10-NOV-2016; lot numbers: L012481, Expiry date: 10-APR-2017) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. On 07-OCT-2016, the vaccines were found to be subjected to a temperature excursion at 21.9C for 1 hour 56 minutes. It was reported that the call was due to a data logger. No Product Quality Complaint (PQC) was involved. This case is linked to case number 1610USA010371, 1610USA012625, 1610USA012626 and 1610USA012628 via same reporter link. Additional information has been requested.
Patient presented with redness to site of pneumococcal vaccine - 4cm area of redness slight warmth. Likely allergic rxn.
AFIB RVR - May 16, 2021  rapid heart beat 150 - 160 started in early am & arrived at hospital around noon (dizziness, light headed, ) cardioversion 200 joules  three shocks ,  plus Diltiazem 20 mg IV , brought heart down to 70-80 and sinus rhythm
2/16/21 New swelling and pain at injection site. Oval slotchy hot rash around the injection site. 2/14/21 Swelling  soreness at injection site and headache
injection site pain tenderness,swelling, redness the next day.Early this morning it started to itch on the injection site .
localized rxn w/chills & aches through the noc;resolved;no record of last dose of vax;
Symptom 1. Had arm pain soreness when lifting arm on 4/14/21 and 4/14/21. Symptom 2. Left upper arm where injection site is started to itch intensely 7 days post vaccine. It was hot to the touch and had large lump under skin. There is also a 1in by 2in red patch/ring around injection site. Noticed this on 4/21/21 at 9pm. It is now 4/22/21 10pm injection site is no longer itchy but does still have a red patch/ring around injection site.  Symptom 3. Not sure if it is related but my right back leg has had bad sciatica pain. Started on 4/21/21
Patient received a dose of Pfizer vaccine where the dose exceeded beyond use dating (BUD) as determined by manufacturer by 5 days.  As advised by Pfizer, they recommended that she receive an additional dose of vaccine as soon as possible to ensure appropriate protection.  Patient's Mom was given this information and will schedule if feels it is necessary.
Patient's arm swelled to twice its size, red itchy rash from armpit to below elbow,  hot to the touch and painful.  Patient also had difficulty breathing so she went to urgent care,  Dr said to take Claritin for the itching and prescribed Doxycyline for upper respiratory issues if it got worse.  Patient did not take the Doxycycline.
No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 15-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2 doses from 1 vial (2.5ml) was initially stored in the refrigerator on 15-Jun-2023 and did not underwent any temperature excursions. No treatment information was provided.   Reporter did not allow further contact
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 75-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included coronary artery disease, gastroesophageal reflux disease, urinary tract disorder (urological difficulties) and arthritis. Concomitant products included omeprazole. On 7th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) 50 ug. On 7th August 2018, 7 hrs after receiving SHINGRIX, the patient experienced fatigue, gastroesophageal reflux, injection site pain, fever and chills. On an unknown date, the patient experienced tremor and feeling abnormal. The patient was treated with ibuprofen. On an unknown date, the outcome of the fatigue, fever and chills were recovered/resolved and the outcome of the gastroesophageal reflux and injection site pain were not recovered/not resolved and the outcome of the tremor and feeling abnormal were unknown. It was unknown if the reporter considered the fatigue, gastroesophageal reflux, injection site pain, fever, chills, tremor and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: At 9 AM, the patient received SHINGRIX. Around 4 PM, 7 hours after receiving SHINGRIX the patient felt fatigued. He often was fatigued in the afternoon, but this time he laid down for about 1 hour and when he got up did not feel any better. He also felt like his stomach was acting up around this time. By 9 PM, 12 hours after receiving SHINGRIX, the patient had chills and a fever of about 102.5 F. He took 600 mg of ibuprofen, but it was difficult for him to open the bottle because he was shaking so hard. He went to bed and over the course of the night his fever went down and by morning it was 89.9 F. The patient also had soreness at the injection site, but no redness or swelling. On 8th and 9th August 2018, the patient's stomach had continued to cause him problems and he had prominent reflux when eating. This case is 1 of the 4 cases reported by the same reporter.
In doctor office at hospital. Just starting to give vaccinations for VFC. Got the T-dap instead of Dtap for a 4 year old. Will watch more closely in getting the right vaccine for the age group. Also moved the tdap to the bottom shelf since it is not for children under 10 years of age,
Mild rash , Vital signs normal, remained for observation for 45 minutes after rash noted.
Per patient's caregiver: low grade fever, patient angry/"messed with his mind", muscle weakness to the point of not being able to get out of bed, nauseated, kidney pain, felt like he was going to die, took a full week before normalization. Patient does not usually have adverse reactions from vaccinations. Will not get second dose in the series due to this event.
Patient reports that the day following the vaccine she experienced chest discomfort that lasted for 1 day. She felt like something was on her chest, felt fluttering in her chest, and felt like she was having a heart attack.
Pt received Pneumo in (R) del and Zostavax in (L) arm sq on 12-3-07. Pt states she had swelling in both arms and had since developed an URI. she has a 50 cent piece welt on (L) arm with redness and pain on 12-10-07. Denies fever. Per doctor order, 1cc Celestone given IM in (R) glut.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAY-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # J006245, expiration date 03-FEB-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 32 hours with the lowest recorded temperature of 31 Fahrenheit degree. The total cumulative excursion time of the second time was 152 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the third time was 584 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the fourth time was 288 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient states there is a knot on her arm in the injection location and that she had been told by the doctor that a nerve had possibly been hit.