chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US023166, is an initial spontaneous report received from a nurse on 06 Nov 2015. This report refers to an adult female patient of an unknown age. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in Dec 2012 at 12:00 PM. On the same day shortly after vaccination (minute after vaccination), the patient had an allergic responses to FLUVIRIN. The patient experienced itching, numbness around the mouth and she felt like her throat was closing. The patient did not experience urticaria. The patient was treated with BENADRYL and the symptoms resolved the same day, before the patient left the clinic. It was stated that, the patient received FLUVIRIN again in 2014 and 2015 at an allergists office with no difficulty and allergic reaction did not occur again. Upon follow up, it was stated that the patient experienced itchy palms and red rash on an unknown date. Reporter did not think that the patient had any other allergies. The outcome of the events hypersensitivity, throat tightness, hypoaesthesia oral and pruritus was reported as complete recovery (resolved) on an unknown date in 2012 and complete recovery on an unknown date for other events. Seriousness of the events hypersensitivity, throat tightness, hypoaesthesia oral and pruritus was reported as non serious and not reported for other events. The causality of the events was not reported. The seriousness assessment of the events was upgraded to medically significant based on information available in the source document. Following an internal review was done on 25 Nov 2015 for the information received on 06 Nov 2015: Seriousness of the event throat tightness was upgraded to medically significant. Follow up report received from a nurse on 01 Dec 2015: Added events (allergic response and numbness around the mouth) and outcome of events. Follow up report received from a nurse on 28 Dec 2015: Added events cold sores and red rash and updated patient details (date of birth) and suspect drug information (dose and time of dose). Follow up report received from a nurse on 20 Jan 2016: Deleted the event cold sores (oral herpes) as the patient did not experience this event.
upon receiving the updated bivalent pfizer covid 19 vaccine, the patient fainted and began to display signs and symptoms of anaphylaxis. she was there with her parents, and was helped to the floor so she was not injured from a fall. A technician yelled for the pharmacist on duty who administered epinephrine while 911 was called. the pharmacist stayed with patient monitoring symptoms until an ambulance arrived. She was taken to the emergency room where she was treated for anaphylaxis. the pharmacist followed up the next day with the family when she picked up her er prescriptions and had appeared to have made a full recovery.
Information has been received from a physician (pulmonologist) concerning a 68 year old male with chronic obstructive pulmonary disease who on an unspecified date was vaccinated with Pneumovax 23 (lot number unavailable). The physician did not know if this was the patient's first vaccination with Pneumovax 23. Subsequently, within 24 hours of vaccination, the patient developed severe swelling and
Focal Myocarditis, verified on MRI and Cardiac FDG PET Mild symptoms on presentation to hospital, asymptomatic after discharge. Hemodynamically stable
Within 15 minutes of receiving the shot, I felt really achy all over, tired, nauseated and wanted to vomit, but couldn't, cold one minute and hot the next, bad headache and my arm started to hurt and itch real bad. I looked at my arm and noticed redness and a rash developing around the injection site. My throat got dry and tight.
Headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced headache on 08Jan2021. Patient stated "I took my second vaccine on Wednesday. And yesterday afternoon and this morning, I have been experiencing headache. Is that part of the vaccine side effects?". The outcome of the event was unknown.  Information on Lot/ Batch number has been requested.
injection site pain; injection site warmth; redness; itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received Shingrix. On 15th July 2019, 3 days after receiving Shingrix, the patient experienced injection site warmth, erythema and pruritus. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, injection site warmth, erythema and pruritus were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, erythema and pruritus to be related to Shingrix.
This spontaneous report was received from a registered pharmacist concerning a 66 year old female patient with no drug reactions/allergies. Concomitant condition of the patient included chronic obstructive pulmonary disease. On 15-NOV-2012, the patient was vaccinated with 0.65 milliliter (ml0 ZOSTAVAX (lot number reported as H013023, expiry date: October 2013), subcutaneously. Patient received oxygen concomitantly, unspecified volume per minute. On an unknown date in November 2012, after the receiving the dose of ZOSTAVAX, the patient experienced headache, body ache and a low grade fever of unspecified temperature. She also reported a large red welt (unspecified measurement) which was too hot to touch for which she saw a physician. Patient sought medical attention (office visit). She was diagnosed with cellulitis at injection site and she was prescribed with unspecified antibiotics (manufacturer unknown). The outcome of body ache, low grade fever of unspecified temperature, headache and cellulitis at injection site was unknown. The relatedness for cellulitis at injection site, low grade fever of unspecified temperature, body ache and headache was unknown for ZOSTAVAX. Additional information has been requested.
soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness on the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness on the injection site). At the time of the report, INJECTION SITE PAIN (soreness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. Treatment information was not provided.
The patient received Tdap vaccine (Adacel) and experienced muscle aches, chills, general malaise, nausea and axillary lymphadenopathy. Symptoms resolved after 6 days.
Breakthrough case admission after 3 vaccines  Pfizer 9/17/21 Lot# ER8732;  Pfizer 10/12/21 Lot# 30155BA; Pfizer 4/25/22 Lot# FM9992
T.C. call from patient states (L) shoulder hot & red at site with pain down her arm into the fingers. Running fever 100-101 degrees for 48 hrs. Advised Dr feels fine 1-28-13.
A few hours after getting the second dose (the one listed), my arm was a bit sore. I went to sleep and woke up in the middle of the night around 4am, extremely cold and my arm was too sore to lay on. I had trouble going back to sleep after waking up.  Later in the day, I went to take my temperature due to being unreasonably cold, and I had a fever of 100.1°F. I noticed the injection site was a bit swollen, red, and warm to the touch. I couldn't eat because I felt too sick to eat anything, it just made me feel nauseated. Later in the day around 6pm or so, I took my temperature again and it was 102.6°F. During the day I was having hot and cold flashes and sweating a lot. Later in the day after waking up from a nap, around 8pm, I started to feel better and my fever went away. My arm was still sore and the injection site is still swollen, red, and warm to the touch. The next day (8/25/21), I felt fine, but my arm was still a bit sore and the injection site was still swollen, red, and warm to the touch.
I had a strong initial reaction with fever of 100 and aches  that lasted for about a day or two. Then I was fine but about 9 days later I started feeling a vibration when lying in bed and sitting in chairs in my house, I thought it was my home at first but then looked up Covid vaccine and see that long Covid symptoms appear as vibrations or tremors, and some have had that after Covid vaccination.. I have constant vibration feelings in my body.
No Adverse Event; Administration of an expired vaccine; Date administered: 30Nov2022 2nd dose/Date administered: 04Aug2022 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Date administered: 30Nov2022 2nd dose/Date administered: 04Aug2022 1st dose) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 083B22A and 011B22A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Type 2 diabetes mellitus, Blood pressure high, High cholesterol and Obesity.   On 04-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 30-Nov-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED   It was reported that nurse gave a vaccine today that expired on 28-Nov-2022 to a patient. Dose administered after 30-day Use By Date or after manufacturer date of expiry.  Individual vials were given. Vial size was reported as 5.5 ml. Vial was removed from the freezer and thawed for administration. The vial did not undergo any temperature excursions.  No treatment information was reported.
Ringing in ears. It sounded like a steam whistle. I thought something was on the stove. I had ringing in my ears with the second dose too but I didn?t think much of it and did not report it.
I experienced pain and swelling of the lymph nodes in the right arm, nausea,  loose stool, no energy, body aches, and a low grade fever (101.0). I did not seek medical care and took Benadryl and Tylenol for my symptoms.
Rash - dark red blotches about the size of a dime; Whole leg is covered with this and it is very unsightly/Rash looks like measles; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles). The patient was treated with CLOBETASOL PROPIONATE for Rash, at a dose of 0.5 %. At the time of the report, RASH MACULAR (Rash - dark red blotches about the size of a dime) and RASH MORBILLIFORM (Whole leg is covered with this and it is very unsightly/Rash looks like measles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14-Jun-2021 and does not contain any new information
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 11-NOV-2014 the patient was inadvertently administered a single dose of ROTATEQ (oral, lot # J004943), that had expired on 05-NOV-2014. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Patient called to ask about "protruding" swelling of injection site. Pharmacist advised her to take ibuprofen and apply cool compresses. Patient called back later complaining of larger swelling and stiff neck. She was told to take BENADRYL, checked on her after 1 hour and she was better.
Evening of shot (L) arm felt sore, next day (L) upper arm was red, warm and tender. T-104 11-9-09 - To office - reddened area (L) upper arm measured 11 x 14 around injection site. Pt c/o fatigue and feeling queasy.
Given yellow fever on 6 mp- for Crohn's (mercaptopurine). Patient has remained healthy.
The patient arm was tingling where the RabAvert vaccine was administered; Case reference number US-BN-2022-002134 is a spontaneous case report initially received on 26-Aug-2022 from a consumer (reference number: USBAV22-1190) and concerns a 5-years-old female patient.  The patient's medical history and concomitant medication details were not reported.  On the unspecified date, it was noticed that the patient had a mark from a possible bat bite.  On 23-Aug-2022, the patient received the first RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown), at an unknown dose and route, in the arm (unspecified), for minimal exposure to rabies (as reported).  On 24-Aug-2022, the morning after being vaccinated, the patient arm was tingling in the place where the RabAvert vaccine was administered.  On 24-Aug-2022, the same day, the event of the tingling extremity was resolved.  The reporter assessed the event as non-serious and did not provide a causality assessment.  Additional information received on 26-Aug-2022 from Bavarian Nordic included local case ID.; Reporter's Comments: A 5-year-old female patient experienced paraesthesia at the administration site (arm), 1 day after 1st vaccination with RabAvert, at an unknown dose and route, administered in the arm for minimal exposure to rabies. The event resolved within the same day. Paraesthesia is listed as per database and insert. The patient was believed to have had a possible bat bite on an unspecified date. No other medical history or concomitant medications were reported. Considering the short latency of the event, as well as the known safety profile, the event of paraesthesia is considered as related to RabAvert.; Sender's Comments: A 5-year-old female patient experienced paraesthesia at the administration site (arm), 1 day after 1st vaccination with RabAvert, at an unknown dose and route, administered in the arm for minimal exposure to rabies. The event resolved within the same day. Paraesthesia is listed as per database and insert. The patient was believed to have had a possible bat bite on an unspecified date. No other medical history or concomitant medications were reported. Considering the short latency of the event, as well as the known safety profile, the event of paraesthesia is considered as related to RabAvert.
Started out with Alopecia areata and is now diagnosed with Alopecia Totallis.
devel morbiliform rash, resolved spontaneously 5-6 days p/vax;
severe diarrhea (blood in stool) (started date 6/9/99);worse p/vax;
Cold chills, shivering, muscle & body soreness, chest congestion, coughing, migraine, sweating, fever, exhaustion..  Treatment: water and pedialyte.   Time course: several hours into the next morning
Subject in pneumococcal vaccine trial, with severe COPD hospitalized w/ coronary artery disease. Vaccination took place 10/31/07. According to physician relationship is 'unlikely'.
Body aches; Fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Daughter)   A female patient of unspecified age received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. Reporter mentioned that her daughter got the vaccine and on an unspecified date had body aches and fever. It was also informed that patient had symptoms like covid, and reporter also asked if her daughter was now positive with Covid after the first dose (as such). At the time of the reporting event outcome was unknown.   Information on the Lot/Batch number has been requested.
test was false positive; tested positive from a rapid PCR test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test) and SARS-COV-2 TEST FALSE POSITIVE (test was false positive) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 11-Nov-2020.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test). On an unknown date, the patient experienced SARS-COV-2 TEST FALSE POSITIVE (test was false positive). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive from a rapid PCR test) and SARS-COV-2 TEST FALSE POSITIVE (test was false positive) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.         No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up information received on 21-JUN-2021 and event (SARS COV-2 test false positive) is updated
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Feb-2021 at 9:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 9:05 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 29.46.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10AM, 11AM, 2PM, 3PM , temperature were 32, 32,32,35,35, respectively, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
18-month-old female patient received the ADACEL with no reported adverse event; Initial information received on 23-Feb-2023 regarding an unsolicited valid non-serious case received from a healthcare professional.  This case involves an 18-month-old female patient who received the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (OMPC) (PEDIAVAX) for Prophylactic vaccination.  On 23-Feb-2023, the patient received dose 1 at 0.5ml total of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection (Strength: standard) (lot number: U7624AA and expiry date: 06-Dec-2024) via intramuscular route in the right thigh for Immunization and an 18-month-old female patient received the adacel with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, caller is wanting to know what to do. This situation is reported as a medication error due to giving to a child younger than 10 years old. First time product used: Yes. Still using product: No.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown.  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.
APPROXIMATLY 30 MINS AFTER PT RECIEVED 2ND DOSE OF MODERNA PT HAD C/O RIGHT HAD SWELLING, TOP OF MOUTH SWELLING AND PT BEGAN COUGHING AND LITTLE AIR MOVEMENT IN LUNGS. 911 WAS CALLED AND ADVICED TO GO TO ER BUT PT DECLINED.  PT REPORTED WOULD GO STRAIGHT HOME TO TAKE DOG HOME AND GO TO THE ER, NURSE HAS ATTEMPTED TO CALL PT SINCE WITH NO ANSWER.  UNSURE IF PT FOLLOWED UP OR BECAME WORSE AT THIS TIME.