chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a rapid heartbeat; blood pressure got high; my heart was skipping beats; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (had a rapid heartbeat), HYPERTENSION (blood pressure got high), PAIN IN EXTREMITY (sore arm) and EXTRASYSTOLES (my heart was skipping beats) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for an unknown indication.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 26-Jan-2021, the patient experienced HEART RATE INCREASED (had a rapid heartbeat), HYPERTENSION (blood pressure got high) and EXTRASYSTOLES (my heart was skipping beats). At the time of the report, HEART RATE INCREASED (had a rapid heartbeat), HYPERTENSION (blood pressure got high), PAIN IN EXTREMITY (sore arm) and EXTRASYSTOLES (my heart was skipping beats) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Blood pressure measurement (120-70): 160/80 (High) Elevated Blood pressure. On 28-Jan-2021, Blood pressure measurement (120-70): 138/80 A little high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient reports she takes blood pressure medicine.
A report was received from a health care professional on 3/1/04 concerning a 2.5 year old female vaccinee who inadvertently received Fluvirin on 12/4/03. On 12/4/03, the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. No follow up pending. All information received.
Started with a lower backache.  By 2:15 PM I had mild shaking in my upper body; by 2:30 PM I had severe, uncontrollable shaking, teeth chattering.  Slightly elevated temp.  Called facility and was advised to take 2 Tylenol.   Fell asleep about 4:00 PM, awoke after 5:00 PM and shaking was gone.  Felt slightly nauseous throughout the reaction.  Felt fine in the morning of 11/4/15.
MOTHER REPORTS THAT SHE NOTED RED FLAT RASH ON PATIENT'S BACK, CHEST AND LEGS AFTER SHOWER ON PM AFTER RECEIVING FLU VACCINE IN MORNING.  PER MOTHER'S HISTORY, THE RASH RESOLVES AND RETURNS, SOMETIMES ON UPPER LEGS OR LOWER LEGS.  PHYSICIAN RECOMMENDED STOPPING ALL MEDICATIONS AND RESUMING SLOWLY AFTER RASH RESOLVES
Pt recv vax on 2/9/99; on 2/20/99 pt exp jaw pain, urticaria & angioedema of hands; tx=Ibuprofen
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Additional Details: pt suffers from needle phobia.
Pt vacc. w/ Engerix-B  2nd dose on 2/8/90.  One week later, developed skin discomfort, "felt like sunburn", arthralgia, generalized aching, which persists.  One month post-vacc., patient developed scleritis in one eye which resolved.
THE NEXT DAY AFTER RECEIVING THE VACCINATIONS, THE PATIENT EXPERIENCED FACIAL SWELLING & TROUBLE SWALLOWING PER VERBAL REPORT FROM DAUGHTER. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE THEY HAVE ADMITTED HER. THE DAUGHTER IS UNCLEAR OF WHAT TREATMENT/TESTS WERE PERFORMED FOR THE PATIENT.
the vaccine was not diluted properly, so patient got higher amount of vaccine than recommended. pt experience no adverse events
In late October 2018 I started experiencing leg and knee weakness and muscle stiffness. The weakness got progressively worse throughout November into December to the point that I feared losing control. My knees felt like they were going to buckle going down steps. The stiffness made it harder to bend over and reach my toes or pick something off the floor. I remember one day walking into a shop when I feared that I was going to drop, my legs were so weak. I started worrying about other muscle diseases, but didn't have time to schedule an appointment with the doctor.  I did not associate this leg weakness at all with the SHINGRIX vaccine that I received Oct. 18th. I had no reaction at the day of injection or the day after, not even a sore arm. Around the same time I also experienced a slight rash on my legs.  It was just small and sporadic wheals that itched occasionally that I assumed was the result of the dry air cause by our electric heat as the temperatures had recently dropped. All I used on my legs was body lotion to moisturize. By the end of the year my weakness abated a bit. Though I could still feel weakness, I no longer feared losing control. I never made an appointment to go into the doctor. On January 23rd I received my 2nd injection of SHINGRIX. This time arm soreness was pronounced and lasted for days. On the 25th of January, 2 days after the 2nd injection, the extreme leg weakness returned and returned quickly. I left very ill with fatigue and malaise and by the evening I could barely walk up the stairs to go to bed. My legs were shaking and felt like rubber. I couldn't sleep however because my heart rate was between 90-100 all night. I know this because I was taking my BP sporadically while I lay in bed. My blood pressure was normal though. The next day the wheals that were on my legs had increased in number and now spread to my upper torso with a few on my arms. They were still sporadic, but were in greater number on my legs. The itchiness increased too. I started using some hydrocortisone cream on the larger spots. It wasn't until the night of the 25th that I finally made the connection with the SHINGRIX vaccine. I wasn't surprised to feel off or lethargic, all standard reactions to vaccines, but the way the leg weakness just intensified again suddenly, I knew the cause. I have never gone in to see the doctor.  I spent the weekend of the 26th and 27th taking it easy and staying off my legs. While I still feel weakness, I no longer fear losing control and falling.  Since the weakness and stiffness abated after the 1st shot, I'm giving it time to do the same now. I didn't think there was anything the doctor could do to help so saw no reason to go in. I am also a pharmacist and work at a Pharmacy.
pt recv vax; mom states infant crying, shrill abnormal,"high pitched" cry lasted  3 hr; to MD who thought was a rxn to pertussis;
His initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-JAN-2011, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-MAY-2015, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as shingles. The patient was prescribed valacyclovir, AUGMENTIN, and hydrocodone for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
Mother stated child ran fever of 103 deg arm became red and swollen at injection site. Mother states child has asthma because of injections.
Cont shoulder pain since vax [2 mos now] slightly improving. Pain was occurring without arm movement in 1st month.
was given Boostrix instead of Infanrix; was given Boostrix, is 15 months old; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23rd September 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2023, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 2nd March 2023, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-Mar-2023 Reporter's comments:  The health care professional (HCP) reported that patient was given Boostrix instead of Infanrix, on the day of reporting. The patient was doing well. The reporter consented to follow up. Additional supportive information: 15 months and 15 days old patient received a dose of Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received an expired dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided. Did the vial undergo any temperature excursions?: No This case concerns a female patient of unknown age with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the event of expired product administered. The event expired product administered occurred right after the unknown dose number of mRNA-1273 vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Extremely lethargic; 102 fever for 24 hours; After fever broke red rash formed on both sides of neck and went from chin, down the neck to the bottom of chest, rash last 2 days; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Er8733) via an unspecified route of administration in the left arm on 29Mar2021 at 14:45 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfonamide. Concomitant medications and past drug were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: En6206) via an unspecified route of administration in the left arm on 08Mar2021 at 14:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 23Mar2021 at 06:00, the patient experienced 102 (unit unspecified) fever for 24 hours, the patient was extremely lethargic and after fever broke red rash formed on both sides of her neck and went from her chin, down on to her neck to the bottom of her chest. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and  emergency room or department or urgent care. The patient did not receive any treatment for the reported adverse events. The clinical outcome of the events fever was recovered on 24Mar2021, after the duration of 24 hours, while that of red rash recovered on 25Mar2021, after the duration of 2 days and lethargic recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Cannot Sleep; Pain at the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025BE18) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site). The patient was treated with IBUPROFEN at a dose of 200 milligram twice a day. At the time of the report, INSOMNIA (Cannot Sleep) and VACCINATION SITE PAIN (Pain at the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Local reaction to varicella immunization. Warm , red, swollen within 24 hours.
This spontaneous report has been received from a pharmacist, referring to a patient whose age and gender was not reported. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medication was not reported. On 22-FEB-2019, the patient was vaccinated with one expired dose of PNEUMOVAX 23 injection, by intramuscular route, for prophylaxis (dose number, frequency and anatomical location of vaccination were not reported; lot number N014188, expiration date 22-JAN-2019). No adverse reaction was reported.
Seizure 10 minutes following administration of influenza vaccine, Tdap, and MENCTRA.
At 15 min lips began to double in size, by 30 min unable to swallow, medical personal quickly reacted and gave me a shot of steroids and shot of antihistamine. Stabilized and left.  Within 24 hours severe vomiting, by 1/16 hives on face, sensitivity to light, migraine, more vomiting. Spoke with dr got prednisone, continued vomiting, 1/19 spoke to PCP Got higher dose of steroids for hives and 8 mg zofran.  1/20-1/22 developed butterfly rash on face similar to lupus. Prescribed more steroids and Ativan to sleep. Follow up scheduled for two weeks
currently have a viral infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VIRAL INFECTION (currently have a viral infection) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VIRAL INFECTION (currently have a viral infection). At the time of the report, VIRAL INFECTION (currently have a viral infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not provided. Treatment information was unknown.
pt recv vax 5SEP97 & 18SEP97 pt devel a 6cm diameter erythema w/mild itching or lt arm below the elbow;dx autoimmune lt brachial plexopathy d/t measles;poss sinusitis or cord edema;
Hypotonic "limp" episode; was unresponsive 3-4 hours, post vax. Paramedics transported to ER and pt was admitted to the hospital for 24 hour observation.
She had a 102 fever, sore throat, headache, congestion, and a cough. She had the cough for about 3 weeks. She was prescribed azithromycin because they thought she had Strep throat. She was prescribed for her acne doxycycline monohydrate, but I don't know if that is what helped her get better from her illness. It seemed to help though.
Pt. was dosed at 12:10 and at 12:30 c/o scratchy throat and lip tingling. He was given 25 mg Benadryl PO and continued to be monitored. At 1:00 no further c/o scratchy throat or lip tingling, pt verbalized emergency management instructions and was dismissed.
Diagnosed with shingles; Developed a red rash; Blisters formed on the right side of torso; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a week after receiving Shingrix, the patient experienced shingles, red rash and blister. On an unknown date, the outcome of the shingles and red rash were not recovered/not resolved and the outcome of the blister was unknown.   It was unknown if the reporter considered the shingles, red rash and blister to be related to Shingrix.  Additional details provided were as follows: The reporter was the patient himself. Patient received Shingrix 1st dose in left deltoid and 4 to 5 days later he developed a Red rash and then Blisters formed on the right side of torso. Patient had a virtual visit with Health care professional and was diagnosed with shingles. Reporter had provided education on Shingrix vaccine, that it is a 2 dose series and it should be given 2-6 months after first dose and that Shingrix is a non- live vaccine. Patient was referred to the health care professional, and provided Medical Information phone number. Reporter did not consent to follow-up.
Slightly Warm at injection site; Itching; Red, at injection site; Sore at injection site; Was probing about two and half inch diameter within 10 days; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red, at injection site), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011-J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Red, at injection site), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days). On 18-Jan-2021, VACCINATION SITE ERYTHEMA (Red, at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Slightly Warm at injection site), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE PAIN (Sore at injection site) and VACCINATION SITE RASH (Was probing about two and half inch diameter within 10 days) was resolving.        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 relevant concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included no new information. On 18-Jun-2021: Non-Significant Follow-up
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 17Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 62 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tylenol, reaction(s): "it makes me go to sleep". The following information was reported: DIZZINESS (non-serious), PRESYNCOPE (non-serious) all with onset 17Mar2021, outcome "not recovered" and all described as "had several dizzy stuff where I almost passed out". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, presyncope. Additional information: The patient take tonic medications and free to susceptible when she take medications. When she tool Tylenol, it made her to go to sleep. Her body did not do well with stuff. Anyways, since she had her COVID shot, she had several dizzy stuff where she almost passed out. The event was persisting. It was not constant but it happens 2 -3 times a day and she was trying to make herself very aware what she was doing when it happens and what was happening to her while it was going on. The patient had not taken anything for it other than she was making herself drink more water but that did not feel to making a difference.  No follow-up attempts are possible. No further information is expected.
Also experienced a headache; Soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247), via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:15 (at the age of 55-year-old) as single dose for COVID-19 immunization. Medical history included COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient did not have allergies to medications, food or other products. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. On 25Feb2021, the patient experienced soreness in left arm following injection that increased throughout the day but was much improved by morning of 26Feb2021.  Also experienced a headache the morning after, on 26Feb2021 which resolved after taking Advil. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event soreness in left arm was recovered on 26Feb2021; headache was recovered in Feb2021.  No follow-up attempts are needed. No further information is expected.
she has an ongoing headache; has been struggling with insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "she has an ongoing headache"; INSOMNIA (non-serious), outcome "not recovered", described as "has been struggling with insomnia".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.