chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot flashes; Night sweats; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy since an unknown date.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intra-abdominal) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats). At the time of the report, HOT FLUSH (hot flashes) and NIGHT SWEATS (night sweats) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Non-significant followup added to include AE contact info,gender,initials updated
Date:20190828  Patient states he has had an increase headaches, and fatigue since he was vaccinated for small pox. Patient states he is drinking 80 oz of water a day and has not changed his diet. Patient reported he was having local itching and redness which resolved when he started using different Band-Aids. 1L of NS was given via 18ga IV in the patient's right AC after being seen by a provider to rule out dehydration. PRE and POST IV administration NS documented. Patient was released on 24hrs Quarters with instruction to return if symptoms worsen or fail to improve.
Initial report received on 14 August 2009 from another manufacturer (document number 45222761) who had received the original report from pharmacist. A 72-year-old female patient received a Poliomyelitis vaccine inactivated, and Typhoid vaccine on an unspecified date "years ago". An unspecified amount of time later, the patient developed typhoid and polio disease. The recovery status of the patient was not reported. No further information was available. Documents held by sender: None.
This spontaneous report as received from a nurse refers to a 6 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Lightheaded and dizziness; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 05Apr2021 at 15:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included dysautonomia and POTS (postural orthostatic tachycardia syndrome); both from an unknown date. The patient did not have any allergies to medications, food, or other products. Concomitant medications included nadolol (MANUFACTURER UNKNOWN), ciclosporin (RESTASIS), magnesium (MANUFACTURER UNKNOWN), ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D) and ubidecarenone (COQ); all from an unknown date for unknown indications. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 15:15, the patient experienced lightheaded and dizziness and brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events lightheaded and dizziness and brain fog was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Within 48 hours, small itchy spots on feet and legs. Within one week large eczema-type spots on front of both legs. Tx: triamcinalone cream, no difference. Rash ithcy burning and open sores. Rash began to creep up legs and invasive to sides of torso.
About 1 week after starting having double vision/blurry vision. Numbness/tingling mouth and eye around left hand (paraphasia from hip to toe). Referred to MS specialist. Taking Vitamin D and Vitamin B supplement.
Non-stop loud ringing in ears, severe sinus pressure, headache, post-nasal drip (thick yellow mucous) achy, chills, earache, sore throat
Patient started w/chills and hot flashes, sweats on 1/19/17 at 3:00 pm. Patient in our office 1/20/17 2:00 pm, still complains of fatigue, lightheaded, painful at vaccination site (L) deltoid. Temp. 98.6 degrees F.
third dose (Booster dose); Experiencing sore; Extreme fatigue; Had fever of 101 and had to take a day off; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administered in arm (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (Manufacture: unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "third dose (Booster dose)"; PAIN (non-serious), outcome "unknown", described as "Experiencing sore"; FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; PYREXIA (non-serious), outcome "unknown", described as "Had fever of 101 and had to take a day off". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Tachycardia (active) Had expected chills, headache, fever (101.5-101.9, oral)... around 6am on 1/28/21, I took a warm shower and had near vasovagal syncope episode after feeling lightheaded and dizzy. As a result, I had mild nausea. If went away after 20 minutes. As the expected chills, headache, and fever continued, I started to develop tachycardia at rest (107-172bpm) with heart palpitations around 9:30am. The palpitations went away approximately 2 hours later. I still continue to have tachycardia with minor shortness of breath sensation.  My heart rate is currently 115bpm at rest. My typical resting heart rate is 65-70bpm.
Information has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who on 03-MAR-2009 and 05-MAY-2009 was vaccinated IM with the first and second 0.5ml doses of GARDASIL (lot# not reported). Then the patient discovered that she was pregnant. No adverse effects noted. The patient sought unspecified medical attention. On 01-SEP-2009. a blood test was performed and it was positive for pregnancy. On 12-OCT-2009, an ultrasound was performed, and it showed normal prenatal ultrasound. The patient's last menstrual period was reported as 15-JUN-2009. The estimated delivery date would be 22-MAR-2010. This is one of several reports received from the same source. Follow-up information was received from a Nurse Practitioner who stated that the patient received GARDASIL. (Both doses were Lot number: 661846/1312X). It was reported that the patient was not sure of diagnosis but was having liver problems (elevated liver enzymes and dermatitis. The reporter stated that the same thing happened with a previous pregnant. It was performed an ultrasound on 01-SEP-2009 with a normal result. According of last week's ultrasound (on approximately 18-NOV-2009) the baby weighs 1 pound. It was also mentioned that the patient would be seen on 01-DEC-2009 by a specialist. The patient sought medical attention in office visit. Additional information has been requested.
This prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of vaccine administration during pregnancy in a 40-year-old female patient who received BOOSTRIX. On 18th September 2014, the patient received BOOSTRIX. The patient's last menstrual period was on an unknown date and estimated date of delivery was 15th December 2014. The patient received BOOSTRIX at week 27 of the pregnancy and during the second trimester of pregnancy. On an unknown date, 1 days after receiving BOOSTRIX, the patient experienced vaccine administration during pregnancy. On an unknown date, the outcome of the vaccine administration during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the reporter considered the vaccine administration during pregnancy to be related to BOOSTRIX. Additional details: Caller reports that she received the BOOSTRIX vaccine while pregnant. Estimated date of delivery is 12/15/2014, it was administered at 27 weeks gestation. Lot and expiration date were unknown. No AEs reported.
Body ache; Severe body pain; Chills; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 19Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years intramuscular, in right arm for immunisation; for immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diabetes. Concomitant medication(s) included: TRESIBA taken for diabetes mellitus; NOVOLOG taken for diabetes mellitus. Vaccination history included: Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 IMMUNISATION; Bnt162b2 omi xbb.1.5 (DOSE 1, SINGLE), administration date: Oct2023, for COVID-19 IMMUNISATION; Influenza vaccine, administration date: 2023, for IMMUNISATION. The following information was reported: PAIN (non-serious) with onset 23Oct2023, outcome "unknown", described as "Body ache; Severe body pain"; CHILLS (non-serious) with onset 23Oct2023, outcome "unknown"; MYALGIA (non-serious) with onset 23Oct2023, outcome "recovered" (Oct2023), described as "Muscle pain". Therapeutic measures were taken as a result of pain, chills, myalgia.  Additional information: on 23Oct2023 the patient did not feel any side effects what so ever Friday, Saturday, Sunday and then Monday, patient started getting chills, body aches and muscle pain and that was the 23Oct2023. Then it went away after he took 3 Ibuprofen. Then Tuesday night, not until 2 AM in the morning he was getting the same thing, the severe body pain, the muscle pain, the chills and then again he took the 3 Ibuprofen and then within an hour that muscle pain was gone and then this morning, patient had to get blood drawn because he is a diabetic and they need to read his blood and then he was going to go MD now, a new Urgent Care to find out about this (Intent : Medical Query) but then he decided just to contact Pfizer first instead. The patient got the COVID (Pfizer COVID-19 Vaccine), two weeks ago. He got the Influenza (Unspecified Influenza Vaccine) a couple of weeks ago and then he just got the RSV the third one. The patient had treatment for just only the RSV that he took the Ibuprofen but the others he did not have any side effects.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Patient has a warm, erythematous reaction (L) arm around injection site measuring 8x9 cm. Area of induration 1cm, no fever, patient already on antibiotics (started 4/20/16) for otitis.
Chronic fatigue syndrome (slept for 6 weeks); slept for 6 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of chronic fatigue syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chronic fatigue syndrome and sleep excessive. On an unknown date, the outcome of the chronic fatigue syndrome was unknown and the outcome of the sleep excessive was recovered/resolved.   The reporter considered the chronic fatigue syndrome and sleep excessive to be related to Shingrix.  Additional Information: GSK receipt Date: 21-DEC-2022 Reporter's Comment: The patient got Shingrix and it kicked up his/her chronic fatigue syndrome. The patient slept for 6 weeks.
On Friday evening, pt had "really swollen arm, really warm to touch, red and hard. Complained of itching at injection site. Was seen in ER: 3 ml Prelone x 3 doses, Benadryl
Fever, headache, body aches, joint aches, weakness, chills. abdomen  pain, severe trembling. Had shot at 4:30pm, woke up the next morning at 6 am and symptoms were there. They got worse during the day. Had issues getting fever down. In the evening was able to break fever and was able to eat. Now second day since injection only have a headache and fatigue.
Body aches, shaking, chills, nausea, headache, episodes of dizziness.  Fever at 1:00 AM on 1/24 was 103°F, gradually went down over next  24 hours to 99°. For about two weeks after that, occasional episodes of mild headache, nausea and dizziness.
20 minutes, post vax, the pt got total body hives; mild facial swelling. No stridor or wheezing. In ER, got Prednisone and Benadryl with rapid response.
thyroid levels had gone up to 4.98; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 12Mar2021 at 12:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure and mitral valve prolapse. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); both from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 13:15, three weeks after receiving the second shot, the patient underwent blood work because of physical coming up. On the day of the blood draw doctor told him that the thyroid levels had gone up to 4.98 (unspecified units) and put the patient on levothyroxine to lower. The patient had planned to retest in 6 weeks. The previous reading of the patient was 2.86 (unspecified units) on 19Nov2019. The patient reported that he did not have history of hypothyroidism, so found this to be strange. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of event and included treatment with levothyroxine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event thyroid levels had gone up to 4.98 was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
My blood pressure went up double from what it used to be; It is painful to open and then to close it back; Pain in right arm right at the wrist, running to my big thumb in my hand; Pain in right arm right at the wrist, running to my big thumb in my hand; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand). At the time of the report, BLOOD PRESSURE INCREASED (My blood pressure went up double from what it used to be), PAIN (It is painful to open and then to close it back), ARTHRALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) and MYALGIA (Pain in right arm right at the wrist, running to my big thumb in my hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) Blood pressure went up double from what it used to be. On an unknown date, X-ray: results not reported (Inconclusive) Results not reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-237415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received contains updated patient demographics and start date of suspect.
Vision changes, weakness, numbness (appears exacerbation of CIDP) starting 1 day after vaccine.
Patient states localized redness and swelling around injection site.  Started approximately one day after injection and was still present on 11/22/2019.
Patient complained of hives on left deltoid, muscle aches, chills, sweating, elevated temperature, left axillary lymph node tenderness, malaise.  Patient took Benadryl and ibuprofen for symptoms.
Was feeling fine the day before, went to sleep around midnight and passed away during the night while sleeping.
Onset of right sided Bell's palsey 12 hours post injection.  The patient has tolerated IM flu injections very well in each of the past 10 years.
Firm area to left thigh with pain for the last 2 days. Refusing to walk.
Chills, Body aches, Fever, Head aches, Stomach cramps, Explosive diarrhea.
This spontaneous case was reported by a consumer and describes the occurrence of CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes), MASS (The patient experienced lumps) and HERPES ZOSTER (Patient also reports having shingles in June 2022.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. Co-suspect product included non-company product HYALURONIC ACID (RESTYLANE) for an unknown indication. Concomitant products included Levothyroxine; Amlodipine; Famotidine; and Raloxifene for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient started HYALURONIC ACID (RESTYLANE) (unknown route) at an unspecified dose. On 05-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced HERPES ZOSTER (Patient also reports having shingles in June 2022.). On an unknown date, the patient experienced CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes) and MASS (The patient experienced lumps). The patient was treated with HYALURONIDASE at a dose of several injections. At the time of the report, CIRCUMORAL SWELLING (swelling around the mouth), SWELLING (swelling under the eyes) and MASS (The patient experienced lumps) had not resolved and HERPES ZOSTER (Patient also reports having shingles in June 2022.) outcome was unknown. Hyaluronic acid (Restylane) was injected for Patient under eyes and around the lips. Patient received several injections of Hyaluronidase (Restylane). It has been stated by treating HCP that for Patient nodules were palpable but not visually noticeable. Treatment information was not provided. This case was linked to MOD-2022-630467 (Patient Link).
Approx 15 min after injection got hot and sweaty developed itchy burning skin on neck and chest and tachycardia. Skin was red with probable hives on chest and neck. Developed rash on neck chest and upper arms. Was triaged by nurses giving vaccine. My blood pressure was 180?s/100?s. I was getting 130-150 heart rate on my watch.  Was given 25mg oral Benadryl approx 25 min after injection. BP was getting higher and sling was burning and itching. Sent to ER for evaluation
Pt recvd 3 doses of Engerix-B on 1NOV90, 29NOV90, & 29APR90 & 15SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
Sore arm; Sore ear/tense to touch feel, on right side 3 days; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm right on 04Mar2021 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, asthma and penicillin allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 16:00, the patient experienced sore arm, sore ear and tense to touch feel on right side, 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore arm was resolved on 06Mar2021, after the duration of 2 days while that of the event sore ear and tense to touch feel on right side was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.