chrisvoncsefalvay/vaers-outcomes huggingface dataset:
consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event; Initial information received on 31-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 years old female patient, consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (hepatitis b vaccine) for prophylactic vaccination; and measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar ra 27/3), varicella zoster vaccine live (oka/merck) (proquad) for prophylactic vaccination.  On 19-May-2022, the patient received a dose of suspect vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine suspension for injection (lot U6990AA, expiry date: 07-Au-2022; strength: unknown) total one day at a dose of 0.5 ml via intramuscular route in the left deltoid as prophylactic vaccination.  On 19-MAY-2022, the consumer only receiving the dtap-ipv portion and not the hib portion due to the staff member not knowing to mix the two parts with no reported adverse event (product preparation error) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  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.
Symptom of hyperthyroid/high thyroid levels in blood; nerve damage in left eye; Symptom of hyperthyroid/high thyroid levels in blood; thyroid issues after had third covid vaccine; Dose 3;   This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (not available). The reporter is the patient. Other Case identifier(s): 21K-163-4164592-00 (Company).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg (citrate free)) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine"; Bnt162b2 (2nd dose), for COVID-19 vaccination, reaction(s): "symptom of hyperthyroid/high thyroid levels in blood", "nerve damage in left eye", "thyroid issues after had third covid vaccine".  The following information was reported: HYPERTHYROIDISM (medically significant), THYROID HORMONES INCREASED (non-serious), outcome "unknown" and all described as "Symptom of hyperthyroid/high thyroid levels in blood"; OPTIC NERVE INJURY (medically significant), outcome "unknown", described as "nerve damage in left eye"; THYROID DISORDER (non-serious), outcome "unknown", described as "thyroid issues after had third covid vaccine"; IMMUNISATION (non-serious), outcome "unknown", described as "Dose 3". The patient underwent the following laboratory tests and procedures: blood test: unknown results, notes: Thyroid issues; thyroid function test: high. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported  events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
From telephone conversation with reported it was stated that a 4 year old (3 of 4) was vacationed with Tripedia, lot UO356AA (date not specified). Some time after the vaccination, the patient developed a local reaction (date of onset not specified). Further information is requested. Linked cases: U200100950, U200100957 & U200100958. From additional correspondence received on 18-Sep-2001, it was reported that the patient, a 2 year old male patient received a Tripedia, an IPOL, an ActHIB, a Hepatitis B, a MMR and a VAR vaccination on 14-Aug-2001. Reportedly on 15/Aug/2001, the patient developed severe swelling of the right leg where the Tripedia and IPOL vaccinations were given. Follow-up #1 received on 9/20/02 indicated that the patient received MMR and Varicella vaccine on 8/15/01, not on 8/14/02 as previously entered. The patient had no illnesses at the time of vaccination and no pre-existing medical conditions. The adverse event coding for peripheral edema was changed to injection site edema. The patient recovered from event. The case is closed.
Patient developed itching, hives was given Benadryl 50 mg and the paient left. Came back over an hour later with her mom and had similar symptoms. We administered Benadryl again. Vital signs were stable. Patient wanted to go to the ED so we provided an ED transport she was discharged on epipen and steroids
Arm hurt for a day; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 15th May 2022, the patient received the 1st dose of Shingles vaccine. In May 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine yesterday (day before reporting) and experienced his/her arm hurt for a day. Additional supportive information: The follow-up would not possible as no contact details were available.
Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events were not reported.  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.; 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.
3/27/21 30hrs flu like symptoms muscle and joint aches/pain and weakness; 3/28/21 24hr physical fatigue, nausea, mental fatigue; 3/29/21 3 days of mental fog, physical fatigue, 4/1/21 No symptoms
Inadvertently administered a dose that was expired.  Expiration date on the vial was 1/16/23.
Systemic: Confusion-Severe, Systemic: Dizziness/Lightheadedness-Severe, Systemic: Fainting/Unresponsive-Severe, Systemic: Flushed/Sweating-Medium, Additional Details: The patient received shot and was waiting in resting area. His wife received her shot. When we opened the door to exit vaccine room, he had fallen and was trying to get up. He had carpet burns on his nose and bruise above right eye. The NP form minute clinic came over took his vitals, heart rate which were normal. She advised he let us call an ambulance to have him checked out for concussion since no one say him fall but patient refused. After 30 minutes patient was able to leave on his own.
Pt turned pale and said she felt "sick". She wanted to go get a drink I had her stay seated and she passed out. M.A. and I picked her up and laid her on the exam table. M.A. got M.D. and I stayed w/pt.  We took her BP when she awoke 120/80.  We let her lie for 15 min. She got up walk around and then discharged.
Baby developed a tremor. It has occurred every day for the past 6 months. She is currently age 12 months. She also developed a lazy eye. She DID NOT display either of these symptoms prior to this set of vaccinations.
Patient received VARIVAX on 5/7/07 in the right thigh. She returns to clinic on 10/09/08 with diagnosis of shingles described in medical record as "localized area of reddened vesicular papular rash with areas of coalescence over right side lower abdomen, onto perineum, right labia. Also with more widely scattered vesicles on right buttock and right upper leg".
Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced swelling and breathing problems in addition to severe swelling under arm, redness on the arm and nodules. At the time of the report, the patient's adverse experiences persisted. The patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Received immunization on 03/10/05. Developed swelling and redness of the right thigh.
Client received 1st COVID vaccine of Moderna (Lot# 021C21A) Client reported a headache. EMT responded to Client. At 6:03PM, vital signs are blood pressure 141/97, pulse 59, oxygen saturation 98%. RN responded to the event. Client had only a salad to eat today and drank plenty of water. Client has no past medical history, no known allergies, no medications. At 6:10PM vital signs are blood pressure 145/98, pulse 59, oxygen saturation 100%. Client reports no blurred vision, no headache, no shortness of breath, no dizziness, no lightheartedness, no nausea. RN provided education in regards to ED precaution and common adverse effects of the COVID vaccine. At 6:15PM vital signs are blood pressure 141/95, pulse 72, oxygen saturation 98%. Client reports slight chest pressure at 6:16PM, states it can be due to possible high cholesterol client may have. RN offered Client to call paramedics for further evaluation. Client declined. Client reports client has not gone to primary care provider in over a year. RN suggested Client to follow up with primary care provider. Client reports chest pain and headache resolved at 6:18PM. At 6:21PM vital signs are blood pressure 139/97, pulse 67, oxygen saturation 97%. Client is able to stand with a steady gate. Client left at 6:24PM with steady gate.
This spontaneous prospective pregnancy report was received from a physician referring to a 27 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On 12-APR-2017, the patient was vaccinated with the 1st dose of GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019 (anatomical route of vaccination was not provided) for prophylaxis. Subsequently, on 14-JUN-2017, the patient was vaccinated with the 2nd dose of GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019 (anatomical route of vaccination was not provided) for prophylaxis. Approximately in 2017, the patient became pregnant (exposure during pregnancy). Information regarding the patient's last menstrual period (LMP) and estimated date of delivery (EDD) was not known. The pregnancy was outcome unknown. The patient had not received the 3rd GARDASIL 9 to complete the series. Testing had not been conducted to confirm pregnancy, however pregnancy could not be ruled out.
Left shoulder pain at time of injection that has persisted 6 weeks with accompanying pain with abduction and limited range of motion of left shoulder and reduced grip strength.
Black out, not feeling well, dizzy. Continued to feel lightheaded and spacey and slightly weak for the next 4 days. Had to go to emergency room on 8/24. Admitted and then began decreasing with weakness, numbness, tingling in legs, back, severe shooting pain, could not walk. Stayed in MC, then transferred to another hospital.
16 yr old registered and received 1st Moderna vaccine and wasn't allowed to get 2nd due to being under 18.  What can she do now? Told we can't switch to a different vaccine and she can't proceed with Moderna.
Head aches, body aches & pain. Severe sinus. Started same week. I would say same day and has not gone away to this day.
TESTED POSITIVE FOR COVID 19; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 11817 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-APR-2021, the subject experienced tested positive for covid 19. Laboratory data included: COVID-19 virus test (NR: not provided) positive. On 10-MAY-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid 19 was not reported. This report was non-serious. This case is associated with a product quality complaint number 90000184582.
Information has been received from a nurse concerning a 28 year old female who is non-sexually active and still has an intact hyman who in January 2008, finished vaccination whith the complete GARDASIL series, 0.5ml, IM.  A recent PAP test for this patient showed her to be positive for high risk HPV and atypical squamous cell of undetermined significance.  The patient sought medical attention.  Additional information has been requested.
7 1/4 x 6 3/4 cm area of redness & warmth (L) upper arm.
Fatigue; Red spot under Covid vaccine injection site; Shingles; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red spot under Covid vaccine injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. In October 2020, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red spot under Covid vaccine injection site). At the time of the report, HERPES ZOSTER (Shingles) had resolved and FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Red spot under Covid vaccine injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or concomitant medications were reported.
Severe diarrhea, dizziness, nausea, general weakness.  Leg weakness, numbness, tingling. Went to ER, Administered IV fluids and medications. Went to Primary Physician on Jan 26, 2010 for Annual Physical Checkup (blood test, pap smear) and told her about the ER visit. Went out of the country for a scheduled vacation (Jan 29-Mar 5, 2010) Went to Hospital while on vacation on Feb 13, 2010 - due to persistent leg weakness, numbness, tingling. Had MRI and nerve analysis. Given GABAPENTIN (30) for neuropathy for one month. Advised to see a neurologist when back home. Made an apptment with Dr. on March 23, 2010. Currently waiting for apptment/visit.
Information has been received from an physician concerning a female with no pertinent medical history or allergies who on 07-JUN-2007 was vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck) (653435/0561F). Concomitant therapy included measles-mumps-rubella vaccine (manufacturer unknown). When the patient had her titers tested for varicella virus vaccine live (Oka/Merck) she was found to be seronegative. No symptoms were reported. No medical attention was sought. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. 3/25/2010 Follow up information was received from the physician concernign a 23-month-old female who on 05-Jun2001 (oreviously reported as 07-Jun-2008) was vaccinated at 5:00 with a first dose of VARIVAX in the "RT". At 1:00 on 08-Nov-007, the paitient had a varicell titier drawn which came back negative.
No additional adverse effect reported; patient received a improperly stored dose of VAQTA; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 06-JAN-2020, the patient was vaccinated with an improperly stored dose (also reported as "1 injection") of hepatitis a vaccine, inactivated(VAQTA) lot # S020241 with expiration date 23-AUG-2020, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse effect was reported. It was stated that the vaccine was exposed to a temperature of -5.7 Celsius degrees for 16 minutes. No previous temperature excursion was reported.
Information has been received from a registered nurse concerning a 27 year old female who on an unspecified dates was vaccinated with the three doses of GARDASIL (dose, route and lot numbers not reported). The registered nurse reported that the patient who completer the series of the vaccine was experiencing missed periods and changes in menstrual cycle. No lab studies were performed. At the time of reporting the patient had not recovered from the events. The patient sought unspecified medical attention. Additional information has been requested.
Fever, Headache, Chills.  101.3 deg temp. Body ache. 24 hr period.  Took Tylonal extra strength to keep fever down, temp broke about 8 AM. Still have headache and body ache.
"Moderna COVID-19 Vaccine EUA" Discomfort swallowing  Bumps on back of throat (like post-nasal drip/allergy)  Headache Tiredness  Red, painful lump at injection site
Client has previous allergies to cows milk and aloe.  Reported her face was hot and swelling after vaccine.  Family member in car with client confirmed her face was swollen as not visible initially. Client tearful  and panicked.  Reclined in car seat and Dr and Epi Pen called for.  Dr spoke with client and examined the swelling, stating her Uvula was swollen.  He administered an epi pen to left thigh muscle.  0.3ml  .  Blood pressure was 135/75 with pulse of 82 RR22 and oxygen saturation of 100%.  EMS on site.  Epi pen was administered on 12.10 pm.  Client responded quickly and stated the she felt much better.  second vital signs in 5 minutes were blood pressure 133/77 pulse 78 RR 18 and oxygen saturation of 97%.  Transported by EMR to hospital.
Appears main discomfort is in the left arm where the PNEUMOVAX was administered. Pt has great difficulty with any movement of the left arm now. Onset of reaction appeared in about 4 hours after administration. The area is said to be sore, itchy, and pt aches all over, has headache, and is not able to sleep well at all because of the discomfort. Pt has tried some ibuprofen for relieve, and is monitoring condition. If situation becomes worse, or not any better by Monday 18, 2017, pt will go into see dr about condition.
A report has been received from a Pharmacist concerning a 60 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 22-Oct-2013. It was reported that consumer was administered FLUMIST QUADRIVALENT to a person over 49 years who was 60 years old which started on 22-Oct-2013. The outcome of the event of administered FLUMIST QUADRIVALENT to a person over 49 years/60 YO is unknown. The report was considered to be non-serious.
Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy). At the time of the report, VACCINATION SITE PRURITUS (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy), VACCINATION SITE RASH (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) and VACCINATION SITE SWELLING (Covid Arm, Itched for 3 weeks, arm broked out, red and swolllen/ itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked: INC.-MOD-2021-057910 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057910:Case for events occured after dose 2