chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; eye pain; headache/ head pain; back pain; chills; Nauseated; her arm was killing her more than a normal vaccine; She had a fever then; This is a spontaneous report from a contactable nurse. This 28-year-old female nurse (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) at single dose at left deltoid for COVID-19 immunisation on 11Jan2021 at 4:30 pm. Relevant history included contraception. Family Medical History Relevant to AE(s) was none. Concomitant drug included ongoing ethinylestradiol, etonogestrel (NUVARING) for contraception for years. The patient experienced a headache, back ache, nausea and was almost passing out. She had the first dose of the vaccine on the 11Jan2021 at 4:30 PM and was in bed around 10:00 that night.  She woke up at 5:00 AM on 12Jan2021 and didn't feel great, her arm was killing her more than a normal vaccine and she was nauseated at 5:30, which was not that horrible. She took some Tylenol. Then she got to work and around 9:00 she felt like she was going to get sick. She had horrendous nausea, chills, weakness, eye pain, headache/ head pain, and back pain. Her clothes hurt because the body aches were so bad. She felt like she was going to pass out, like a vasovagal. She went to urgent care because her manager didn't think it was side effect. She went and got swabbed (result unknown), whatever. She had a fever then. They told her it was a reaction to the vaccine. Her temperature was 101.6 degrees Fahrenheit when she went to Urgent care. She would say the fever started at 12:30PM on 12Jan2021. She did not know if fever would be ongoing because she was taking fever reducer and it was working. The events weakness, eye pain, head pain, and back pain were reported as serious since medically significant. The nausea was better around 2:00PM. The outcome of event nausea, Chills was and Weakness was resolved on 12Jan2021.  The outcome of events eye pain, head pain, and back pain was resolving. The outcome of event 'her arm was killing her more than a normal vaccine' was recovering. The outcome of fever was unknown. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events, weakness, eye pain, head pain, and back pain, and the administration the suspect vaccine, BNT162B2.   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 RA, IEC, as appropriate.
Foot cramping on and off; Shoulder pain/ Uncomfortable Shoulder; Myalgia on the same side as the vaccine was administered; She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder), MYALGIA (Myalgia on the same side as the vaccine was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder), MYALGIA (Myalgia on the same side as the vaccine was administered) and PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination). On 12-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (She states that the person whom vaccinated her did not let the vaccine stay at room temperature for 15 minutes prior to vaccination) had resolved. At the time of the report, MUSCLE SPASMS (Foot cramping on and off), ARTHRALGIA (Shoulder pain/ Uncomfortable Shoulder) and MYALGIA (Myalgia on the same side as the vaccine was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Bell's Palsy-Medium, Systemic: Exhaustion / Lethargy-Medium.
condition was 48.9F for 7 days due to a refrigerator malfunction on 3-Feb-2023 with no reported adverse event; Adacel was administered post excursion with no reported adverse event; Initial information received from on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient and it was reported that condition was 48.9f for 7 days due to a refrigerator malfunction on 3-feb-2023 and diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] was administered post excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitants and family history were not provided.   It was reported that the condition was 48.9f for 7 days due to a refrigerator malfunction on 3-feb-2023 with no reported adverse event (product storage error) and on 09-Feb-2023, a dose of 0.5 ml (1X) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] suspension for injection (batch/lot number: U7648AA and expiry date: 15-feb-2025; strength: unknown) was administered via intramuscular route in the left deltoid for immunization post excursion with no reported adverse event (poor quality product administered) (latency: same day).  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for 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 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.; Sender's Comments:  01489250: 01489329: 01489354:
2nd visit to ED after also being hospitalized. Diagnosis on 10/3:  Reason for Visit  Shortness of Breath  Diagnoses  0 SOB (shortness of breath) 0 COVID-19 virus infection 0 Pneumonia of right upper lobe due to infectious organism 0 Hypotension, unspecified hypotension type  transferred to hospital
Later that evening site became very swollen, sore, warm to the touch and reddened.
This case was reported by a healthcare professional and described the occurrence of nausea in a 4-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included unspecified vaccine given on an unspecified date. On 15 March 2011 the subject inadvertently received an expired 2nd dose of ROTARIX. At an unspecified time after vaccination with ROTARIX, the subject experienced nausea and vomiting. It was noted that the subject had an unspecified gastrointestinal problem prior to vaccination with ROTARIX. At the time of reporting the outcome of the events was unspecified. Attribution of events to ROTARIX was not provided.
dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event; Initial information received on 20-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of unknown demographics who had dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 09-Sep-2022, the patient received a first dose of suspect RABIES (HDC) VACCINE (formulation, strength, route: unknown)  lot number not reported in unknown administration site as Immunization  On 09-SEP-2022 the patient had dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event (inappropriate schedule of product administration) same day following the administration of RABIES (HDC) VACCINE.  On 12-Sep-2022 he/she also received a second dose of the same vaccine  with an unknown batch number in unknown administration site. On 20-Sep-2022 he/she also received a third dose of the same vaccine  with an unknown batch number in unknown administration site as Immunization, where the 3rd was supposed to be on 16sep2022.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (dosing of imovax, using pre-exposure schedule instead of post-exposure unvaccinated schedule and giving 3 doses with a booster instead of 5 doses for post-exposure unvaccinated with no reported adverse event).  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 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.
Slight soreness of the injected left arm; headache; Feeling hot; Terrible whole body pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site pain, headache, feeling hot and general body pain. On an unknown date, the outcome of the injection site pain, headache, feeling hot and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, feeling hot and general body pain to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of Shingrix vaccine in left deltoid and experienced soreness of the injected left arm and headache. Both injection site pain and headache were resolved . The headache lasted only a few days. The patient stated that about 1 to 2 months after receiving the vaccine, one night she woke up feeling hot with terrible whole body pain which resolved in about 10 minutes. The reporter consented to follow up.
doses administered after excursion; No adverse event; Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 43-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, 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 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No Concomitant medications were provided. Reporter reported that a temperature excursion that occurred several days ago in the Freezer. The excursion was found out in an audit and all the vaccines were viable. Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.  No treatment medications were provided.
Member has possible swollen lymph node on left clavicle, post smallpox vaccination.
Neuropathy / is going to receive Shingrix´s 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gammagard). On an unknown date, the outcome of the neuropathy was not recovered/not resolved.   It was unknown if the reporter considered the neuropathy to be related to Shingrix.  Additional information was provided as follows: The reporter stated that a patient who was currently receiving Gammagard because of a neuropathy and the patient was going to receive Shingrix 2nd dose. No other information about the patient´s medical condition was provided and did not have any vaccine information. The reporter consented to follow up. No further information was available.
Moderna Covid-19 vaccine was given after being left out then given at 19hr mark; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was given after being left out then given at 19hr mark) had resolved.        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.   No relevant concomitant medications were reported.  No treatment information was reported.
FROZEN VACCINE WAS THAWED AND GIVEN TO PATIENT; This spontaneous report received from a pharmacist concerned a 56 year old of unspecified sex. 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, intramuscular, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-JUN-2021, the subject experienced frozen vaccine was thawed and given to subject. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of frozen vaccine was thawed and given to patient was not reported. This report was non-serious.
Patient developed an non-pruritic rash on her face, then appeared on her upper and lower extremities. She has a low grade fever that started on 7/31/19, it is improving and thought to be viral exantham.
Received anthrax annual booster in left arm. The next day the pt noticed redness and induration at the site which got worse until 3/17/08 when he presented with 11cm of erythema and 7cm of induration. Tx with topical steroids, warm compresses and Tylenol (pt unable to take NSAIDS). By 3/24/08 only had small amount of redness and induration at the injection site.
Body aches, fever, heart palpitations, swollen lymph nodes, especially around breast, heavy menstruation following 2nd vaccine shot
Information has been received from a physician concerning a 11 year old female who on 25-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) in the deltoid region of her arm. On 26-JUN-2008 the patient developed a rash from the wrist to the elbow on the arm in which she received the GARDASIL vaccine (yeast). The patient was treated with diphenhydramine hydrochloride (BENADRYL). The patient sought medical attention by telephone call. Additional information has been requested.
Severe soreness in left arm after shot. Next day, soreness was followed by severe aches in shoulders and shooting down to wrist. Discussed the aches with Dr, who was treating my right shoulder due to a fall in August. He prescribed pt. symptoms continue.
Pain at injection site in three hours of shot. Pain moving arm 5 hours after shot. 14 hours after shot assorted body aches and tummy issues. Felt almost like flu symptoms.
Pt received bivalent Moderna booster in error without first completing a primary covid vaccine series. Pt will come back in 8 weeks, at the recommendation of MD for his first Moderna primary dose.
MA based on patient's age as to what imms to give rather than the fact that the child was missing other vaccines due to patient interference of the recommended schedule.
he had a poison ivy rash/Arm rash; Swollen arm; This is a spontaneous report received from a contactable consumer (reporting on himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient, called to say that tomorrow on 21APR2021, his 2nd dose schedule together with his wife. wanted to know if he can get his 2nd dose tomorrow, he has a poison ivy rash because he gardened last week or if they need to reschedule their 2nd dose. Patient experienced swollen arm and arm rashes and he's taking Prednisone 6 days medication for his rashes on his skin. Caller mentioned that his rash was not mild, it's severe. And His wife received their 1st dose on 30MAR2021. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included CITALOPRAM, PRENATAL VITAMINS [ASCORBIC ACID; BETA CAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE] and IRON for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Jun-2020 and the estimated date of delivery was 16-Mar-2021. On 27-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy.  On 27-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Internal review on 21-JUL-2021 resulted in update of Reporter details , Gestation period, Birth type , Fetal outcome, Action taken with suspect drug .
Severe pain in arm, severe aches and joint pain over entire body, back ache, high fever, dizziness, lightheadedness, cough, extreme fatigue.  Lasted 2 1/2 days.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019)  or  (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT).   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
Onset of fever (tactile) the evening the immunization was given and sore throat. Pt was seen by provider on 9/11/02-tem 101.4 (R). Mild pharyngitis noted on exam. Throat culture sent rx with Tylenol pending TC result.