chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt like she had been hit by a truck; left arm swelled up; random hives (on her left arm, above thumb and crease of arm and sides); Fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot on 13-Oct-2021. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included COPD, Drug allergy (prednisone injections) and Allergy (adhesives including band-aid adhesives). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for COPD.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever). At the time of the report, FEELING ABNORMAL (Felt like she had been hit by a truck), PERIPHERAL SWELLING (left arm swelled up), URTICARIA (random hives (on her left arm, above thumb and crease of arm and sides)) and PYREXIA (Fever) outcome was unknown.            Patient  stated she was on a lot of medications and have been on them for many years but did not list the medication names.   This case was linked to MOD-2021-376927, MOD-2021-376967 (Patient Link).; Sender's Comments: This case concerns a 71-year-old, female patient with relevant medical history of drug (prednisone injections) and adhesive (Band-aid) allergies, who experienced the unexpected, non-serious events of feeling abnormal, peripheral swelling and urticaria, and the expected, non-serious event of pyrexia. The events occurred on the same day after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was positive for all events as these recurred after administration of the booster dose of the Moderna COVID-19 Vaccine. The medical history of drug and adhesive allergies remain as confounders for the peripheral swelling and urticaria. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Of note, the patient stated that she is 'on a lot of medications and have been on them for many years'. These may also be considered as confounders for the peripheral swelling and urticaria. Further information has been requested.
Eyes swollen shut; Tingling/prickling/burning in the legs; Intermittent ringing in the ears; Sore arm; Hives; Fever of 102.2; Fatigue; Frequent headaches; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swollen shut), PARAESTHESIA (Tingling/prickling/burning in the legs), TINNITUS (Intermittent ringing in the ears), PAIN IN EXTREMITY (Sore arm) and URTICARIA (Hives) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Hypercholesterolaemia. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) for Diabetes, ATORVASTATIN for Hypercholesterolaemia.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced EYE SWELLING (Eyes swollen shut), PARAESTHESIA (Tingling/prickling/burning in the legs), TINNITUS (Intermittent ringing in the ears), PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives), PYREXIA (Fever of 102.2), FATIGUE (Fatigue) and HEADACHE (Frequent headaches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (Eyes swollen shut), PARAESTHESIA (Tingling/prickling/burning in the legs), TINNITUS (Intermittent ringing in the ears), PAIN IN EXTREMITY (Sore arm), URTICARIA (Hives), PYREXIA (Fever of 102.2), FATIGUE (Fatigue) and HEADACHE (Frequent headaches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 102.2 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow up received included no newsignificant information. On 05-Aug-2021: Follow-up information received on 05-AUG-2021 include no new information.
Pneumonia; Cough; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant) and COUGH (Cough). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (Pneumonia) had resolved and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was hospitalized on 6Apr 2021 for pneumonia and discharged on 9Apr2021. She has cough at present and she is on antibiotics.  Company comment:Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although the presentation of the pneumonia more than 2 weeks after receiving first dose of mRNA-1273 (Moderna COVID-19 Vaccine) suggests an alternative cause is possible.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded, although the presentation of the pneumonia more than 2 weeks after receiving first dose of mRNA-1273 (Moderna COVID-19 Vaccine) suggests an alternative cause is possible.
2 days after the vaccine administration the patient developed a rash.  The wife of the patient gave him Benadryl which helped with the rash.  The wife called the pharmacy 04/11/23 to report the event of a rash but patient was doing okay.  On 04/12/23 patient called pharmacy again and was upset stating that the rash was diffuse and patient was sick but then stated he was better.  Details are a little confusing because she then claimed that he had an immune system issue which was not disclosed on the vaccine questioner.
ON 4/29 WAS GIVEN TOO EARLY, PATIENT IS NOT IMMUNOCOMPROMISED NOR MEETS AGE REQUIREMENTS FOR A SECOND BOOSTER YET
This happened only after my 2nd dose. At night after going to sleeping around 10:30pm, my heart was pounding (beating heavily and fast) all night. There was no pain, but I could not sleep. It was somewhat difficult to breathe but I was having some difficulty due to the rhinitis beforehand.  In the morning, (around 8am) my heartbeat was back to normal (possibly a couple hours before). I went downstairs and sat on my couch and fell asleep for ~2 hours. After that I had flu-like symptoms the rest of the day but no fast heart beating.  This same fast heartbeat happened again (but to a lesser severity) after my booster dose on 12/1/2021. It happened after I went to sleep around 10:30pm.  I did not know this was an adverse event until after the booster dose while reading of such events online. Therefore, I did not seek medical attention. None of the doctors I had seen over the past year for my rhinitis had told me about this potential adverse reaction.
This spontaneous report was received from a doctor of pharmacy refers to a 63 year old male patient with no drug reaction or allergies. Medical history included cold sores. On 20-JUN-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date not reported) subcutaneously. Approximately on 20-JUN-2013 the patient experienced headache immediately following administration of ZOSTAVAX that went away approximately on an unknown date in June 2013. It was unknown if patient treated the headache. On 23-JUN-2013, the patient developed a cold sore which had not yet been treated and had not yet gone away. No laboratory diagnostic studies were performed. Causality was not reported. Additional information has been requested.
Hives, Dermatographia. It has been ongoing for 2 months. I occasionally take Zyrtec or Benadryl.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 29-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Herpes zoster rash 2 x 4 cm right thorax, pain right ribs, both for past 7 days.
An attorney alleges that a female received an injection of Flu Shield (200-2001 formula) on or about 11/03/2000 and subsequently suffered an unspecified serious and permanent bodily injury. It is alleged that she subsequently suffered physical and mental pain, permanent bodily disfigurement, and permanent impairment of her ability to labor and earn money. No further info was available at the date of this report. The follow up states this report was determined to be a duplicate of report HQ5486904SEP2001.
Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.
anxiety; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing); "burn from her elbow to wrist", start date: 28Mar2021 (unspecified if ongoing); "Pain" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for pain; ADVIL NIGHTTIME taken for pain. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Two days before the 2nd vaccination she suffered an accidental scald burn, her brother, an anesthesiologist recommended and an antibiotic ointment and taking 2 Tylenol + 2 Advil for pain. This was 2 nights before she got her covid vaccine. Then she took a half of a Tylenol the night before she got her vaccine. She didn't want to take anything before the vaccine because she was worried it wouldn't work. Patient states she runs with anxiety in general and states she has a lot of anxiety about this and wants to know if it will affect how the vaccine works for her. Mentioned that not knowing if her medications will impact the COVID-19 vaccine efficacy is causing anxiety.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
right arm pain/right leg/left leg pain; It was hard to walk; Knee pain; cramps because she still bleeds; clarified as she still gets her periods; This is a spontaneous report from a contactable consumer (parent). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in 2021 for COVID-19 immunization. On an unspecified date, the patient experienced the pain first started in the left leg then it would go to the right leg and then back and forth. The last time, it would settle in the right leg. It was hard to walk. Then, she would elevate the leg and it would go away. Then it would come back and settle in the knee. Today, was a good day for her, and she did not have any pain. She also reported pain in right arm. Treatment: She believes she took Ibuprofen, which she also takes to help with cramps because she still bleeds; clarified as she still gets her periods. She is not on any other medications. The patient did not went to the ER but to the physician office for the pain in leg. The doctor gave her a prescription and she went to get it filled. It was inaccurate. She had it and didn't take it. She took it one time and whatever they recommended was the wrong medication. The patient did not know the name of the medication. Outcome of events was unknown.   Information on the lot/batch number has been requested.
My arm where I got the vaccine is red; My arm where I got the vaccine swollen; 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 VACCINATION SITE ERYTHEMA (My arm where I got the vaccine is red) and VACCINATION SITE SWELLING (My arm where I got the vaccine swollen) 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 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (My arm where I got the vaccine is red) and VACCINATION SITE SWELLING (My arm where I got the vaccine swollen). At the time of the report, VACCINATION SITE ERYTHEMA (My arm where I got the vaccine is red) and VACCINATION SITE SWELLING (My arm where I got the vaccine swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
MD report via telephone 9MAR92 @900; symptomatology pt because stiff & apneic for 30 seconds that evening p/date of vax;
11/24/22 I had fever and chills. My temperature got up to 101.4. The next day I took some heavy-duty TYLENOL and that helped bring the temperature down some. I went to the doctor the next day. They did a COVID test, and a flu test and the flu test was positive. They prescribed TAMIFLU for 5 days. I am now over the flu.
On Tuesday the injection site developed hives. On Wednesday I felt very sick. On Saturday I lost all sense of taste and smell.
As soon as the nurse gave the patient the HPV vaccine the patient immediately stated that she felt "weird". Patient's mom stated that she was nervous and that she had not eaten this am.  Within 5 minutes the patient started to vomit, began sweating and became pale. Vital signs were assessed and were within normal range, NP came in and assessed patient. We provided patient with water and a cool cloth. The provider diagnosed her with having a vaso-vagal reaction. We monitored patient and she left the office a little before 10:30 as she was feeling better.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 04-JUN-2013, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 13-JUN-2013, the patient was treated at an Ophthalmology group, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the 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. Additional information has been requested.
Second dose administered greater than 35 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose). In December 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered greater than 35 days after the first dose) had resolved.            No concomitant medications were reported.  Treatment information was not provided.
Fever of 100.0; fatigue; chills; headache; body aches; This is a spontaneous report from a contactable nurse(patient herself).  A 33-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK9231, expiry date unknown), via an unspecified route of administration in right arm on 07Jan2021 at a single dose  for COVID-19 immunisation.  Medical history included depression. The patient had no known allergies (NKA). Patient was not pregnant at the time of vaccination.   Concomitant medication included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of BNT162B2 (lot number: EH9899) on 17Dec2020 for COVID-19 immunization and experienced body aches and recovered. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced with second shot fever of 100.0, chills, headache, body aches, fatigue on 08Jan2021 at 01:00 AM. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on unspecified date.
This spontaneous retrospective pregnancy report was received from an approximately 41 years old female pharmacist, regarding herself. Patient had no relevant medical history and no drug reactions/allergies. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and frequency unknown). Patient's concomitant medication was not reported. On an unknown date the patient had a miscarriage in 2013 (approximately) (medically significant), D and C procedure (medically significant) and she took off of work for two weeks after her miscarriage (disability). It was reported that, about a year ago the patient was 3 months pregnant (last menstrual period approximately February 2013 and estimated delivery date was approximately November 2013) and had a miscarriage (approximately 2013). The reporter states that during her pregnancy, she administered ZOSTAVAX to an unspecified amount of patients. She reported that she went to an unspecified emergency room on an unspecified date where it was discovered that she has a miscarriage. The reporter also stated that she took off work for two weeks after her miscarriage and that during that time, she had a dilatation and curettage (D and C) procedure. Laboratory studies were not performed. Patient was not hospitalized. Product quality complaint was not involved. The outcome of the events was unknown. The reporter's causality assessment was not provided. Upon internal review, the event of miscarriage was considered to be medically significant. Additional information has been requested.
Hot warm flush feeling throughout body, chills, later in the day, tongue starting burning and swelling around edges of tongue, went to ER and received Benadryl and stayed for 2hrs. sent home with an EpiPen. burning feeling in tongue persisted. went back to ER due to tongue swelling.
Persistent Coughing, dizziness, Lightheadedness, congestion, still continuing to a degree, pressure behind eyes.
Paresthesia (pins & needles) L arm (vaccination arm) and hand (especially) including all five digits.
Stomach pains for 3-4 days until I saw the doctor. The doctors change too much so I won't name the current one that I saw. They are thinking it's very plausible that I have GERD. They gave me Gerd medication (Famotidine and Omeprazole) and a tract.
administered an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) 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.   Concomitant medication details were not reported by the reporter.  Treatment details was not reported by the reporter.