chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult female patient who experienced received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants (antibody test abnormal) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No Lab data was reported. Final diagnosis was received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants. Documents held by the sender: none.
second dose administrated 55 days after first dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after first dose) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administrated 55 days after first dose) outcome was unknown.            Concomitant product use was not provided by the reporter.   Treatment information was not provided.
skin began to feel sore; my temperature is slightly elevated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (skin began to feel sore) and BODY TEMPERATURE INCREASED (my temperature is slightly elevated) 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 21-Jun-2021 at 9:00 AM, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced BODY TEMPERATURE INCREASED (my temperature is slightly elevated). On 21-Jun-2021 at 4:00 PM, the patient experienced PAIN OF SKIN (skin began to feel sore). At the time of the report, PAIN OF SKIN (skin began to feel sore) and BODY TEMPERATURE INCREASED (my temperature is slightly elevated) outcome was unknown.            No concomitant medications were provided.  No treatment was reported for the events.
Next day - headache and extreme fatigue (sluggish).  Slight chills, no fever.  These symptoms only lasted for 24 hours.
Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00204, 0708USA00508, 0708USA00509, 0708USA00510, and 0708USA00511). Additional information has been requested.
An early period with cramps and full on bleeding was induced. Today, a piece of dark matter fell out of my vagina while using the toilet.
Fever 102.4, chills, body aches, nausea, tiredness  Fever hovering around 99.2 the next day
Fever (104.4), rash began 05/22/2005 - visited ER and Followed up with regular MD.  MD opinion that is reaction to MMR vaccination.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 08:20, the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000486: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
About 4 days after her 2nd COVID vaccine shot, my daughter was very fatigued. Then she started to have a higher than normal heart rate on runs - roughly 11 bpm higher (she runs cross country and track and tracks all her runs).  We went to the doctor around the middle of June and they ran some tests. Several of her blood tests can back out of range but more starting was her TSH was extremely low. They started running several thyroid tests.  It is important to note that she has a blood panel run in late March 2021 and her TSH level was normal, ~3.0 pg/mL.
Hair growth on her upper lip/"a full mustache"; This spontaneous case was reported by a consumer and describes the occurrence of HIRSUTISM (Hair growth on her upper lip/"a full mustache") 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HIRSUTISM (Hair growth on her upper lip/"a full mustache"). At the time of the report, HIRSUTISM (Hair growth on her upper lip/"a full mustache") outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reporter stated that patient experienced adverse event after completing Moderna vaccine series.
Initial unsolicited report received from a healthcare professional on 23-Jun-2017. This case is linked to 2017SA118239 (same reporter). This case involves a patient (gender and age were not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number, expiration date, dose, dose in series and site of administration were not reported) intramuscularly on an unspecified date. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and illness at the time of vaccination were reported as unknown. Concomitant medications were not reported. On 04-Oct-2016, following the vaccination, the patient developed an autoimmune disorder. The patient required emergency room/doctor visit. Laboratory investigations were reported as unknown. Corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review, the company decided to consider the case as serious due to important medical event: autoimmune disorder. List of documents held by sender: none.; Sender's Comments: Sanofi company comment dated 28-Jun-2017: This case concerns patient who was vaccinated with FLUZONE QIV and had autoimmune disorder. Time to onset compatibility is unknown with the role of vaccine, medical history, immunological history, any autoimmune disorder in family member, more investigation results to rule out the alternative cause, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Approximately 16 minutes after patient received the vaccine they felt nausea like they wanted to throw up, possible because they became dizzy. They also felt as if they were going to faint and expressed visual disturbances. Patient laid down flat on there back and moment later began to feel better. She did not lose consciousness at all. Patient also expressed a sharp pain in her back, but had said right before she felt bad she lifted her 5 year old daughter; it is unclear if the sharp back pain was due to the vaccine. When she left the pharmacy 15minutes later she was able to walk just fine and said she felt better and felt like herself again.
On Jan 12th developed sever left upper abdominal pain or left lower rib pain.    After Ct scans left lower lung atelectisis and splenomeglia .    Also enlarged Lymphnodes in the Mesentergic areas.
Headache, chills, fatigue, body ache Symptoms began on 01/18/21 , 6pm Subsided approximately 12N, 01/19/21
Chills; Fever; Blood pressure went up to 160; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160). The patient was treated with PARACETAMOL (TYLENOL) at a dose of unknown. On 18-Apr-2021, CHILLS (Chills), PYREXIA (Fever) and BLOOD PRESSURE INCREASED (Blood pressure went up to 160) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-043592 (Patient Link).
Pt states that when he got home from the clinic after his appt. he noticed the redness at the injection site. Pt states that the next morning the redness had grown in size. Today the size of the redness is doubled. Skin warm to the touch and tender to the touch.
Knots on B thighs where shots given. Legs swollen per mom after shots but not on day of office visit.
bodyaches; tired; fever; cough; HEACHACHES; SWELLING; REDNESS; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL) and GUAIFENESIN (MUCINEX) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SWELLING (SWELLING) and ERYTHEMA (REDNESS). On 15-Feb-2021, the patient experienced PYREXIA (fever), COUGH (cough) and HEADACHE (HEACHACHES). On an unknown date, the patient experienced PAIN (bodyaches) and FATIGUE (tired). At the time of the report, SWELLING (SWELLING), ERYTHEMA (REDNESS), PYREXIA (fever), COUGH (cough), HEADACHE (HEACHACHES), PAIN (bodyaches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2hr p/inj red spots around inj site & was sore all over;3hr later rash progressed down arm & on legs;states had no SOB or tightness but felt tired;11PM took DPH tabs;next day rash became larger;
Rash on torso, some on legs, relieved with use of Benadryl and cortisone cream.
Arm was painful (8/10), redness noted to injection site, redness noted to front of shoulder very painful to move and redness to about middle of clavicle with a red raised lump on the clavicle; the next morning, red lump to left axilla lymph node, very painful (8/10) to touch.
6cm circular red area with warmth and tenderness to touch to left thigh. Located below injection sites x 2. Started 1 day after injections administered. TX: TYLENOL/MOTRIN for discomfort and cool compresses to site.
Patient received a second dose of Pfizer Bivalent vaccine approximately 4 months and 9 days after receiving the inital Booster.  He is reporting no adverse reactions at this time.
Donor had vaso-vagal response following anthrax vaccination - Prior to vaccination donor donated 900 mls plasma - Donor states he did not eat prior to donation. During reaction donor unresponsive < 30 seconds - Donor incontinent bowel and bladder. Donor treated per protocol, he was laid supine, Oxygen admin 6 l prn via nasal cannula, normal saline admin 500 ml. Initial vitals during and after event. 4:26 pm BP 80/p pulse 120+. At 4:35 pm BP 101/62 Pulse 84. At 455 pm BP 110/70 Pulse at 90. After treatment - donor recovered well, oral fluids given along with granola bar, donor left center without incident. Donor was contacted the following day and stated he had no adverse problems from incident and was feeling well. Medical director requested VAER's due to reaction occurred quickly after vaccination. VAERS completed due to uncertainty of cause of reaction.
Coughing; This case was reported by a consumer and described the occurrence of cough in a female 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 cough. On an unknown date, the outcome of the cough was not recovered/not resolved.   It was unknown if the reporter considered the cough to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: This report was submitted via the online direct entry reporting system. The office staff reported that the patient received a dose of Shingrix and experienced coughing as a side effect. The reporter consented to follow up.
This spontaneous report was received from a healthcare professional regarding unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were unknown. The reporter stated that since 01-OCT-2015 till December 2015, unspecified number of patients were vaccinated with improperly stored M-M-R II (lot K024035 expiry date 26-NOV-2016 and lot K004949 expiry date 04-APR-2016, route, site of administration, dose unknown). The vaccine was stored at unknown temperatures exceeding 46F for an unspecified duration. There was no previous temperature excursion. This was not part of any digital data logger. The reporter was not aware of any adverse effects. This is one of the several reports from the same reporter.  Additional information has been requested.
Nasty rash after second Shingrix vac; This case was reported by a consumer and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient nasty rash after 2nd Shingrix shot. The patient asked the duration that the rash might last..
visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color"; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Macular degeneration ((wet, dry)), Arthritis, Asthma, Coronary artery disease, Diverticulosis, Barrett's esophagus (Barrett's esophagus III), GERD and Glaucoma (Suspected glaucoma). Concomitant products included MONTELUKAST SODIUM (SINGULAIR), AMLODIPINE BESILATE (NORVASC), EZETIMIBE (ZETIA), CELECOXIB (CELEBREX), DEXLANSOPRAZOLE (DEXILANT), ROSUVASTATIN CALCIUM (CRESTOR), FAMOTIDINE (PEPCID [FAMOTIDINE]), ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2), FISH OIL, UBIDECARENONE (CO Q-10), THIAMINE HYDROCHLORIDE (VITAMIN B-6), THIAMINE HYDROCHLORIDE (VITAMIN B-12), BRIMONIDINE TARTRATE, BRINZOLAMIDE (SIMBRINZA), DICLOFENAC (VOLTAREN [DICLOFENAC]), RANIBIZUMAB (LUCENTIS) and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color"). On 09-Feb-2021, VISUAL IMPAIRMENT (visual disturbances/saw "a small elongated triangle that was orange in color"/saw "a small elongated triangle that was blue in color") had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Information has been received from a physician concerning a 7-year-old male who on 08-SEP-2000 was vaccinated with Varivax. On 03-JAN-2007 the patient experienced chickenpox. Unspecified medical attention was sought. It was reported that the patient was recovering at the time of this report. No additional information to report. There was no product quality complaint. Additional information has been requested.
About 2 hours after administration, developed hives, a thick tongue, found it hard to swallow and had lightheadedness.
Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not; Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION COMPLICATION (non-serious), MUSCLE STRAIN (non-serious), outcome "unknown" and all described as "Accidentally pulled her arm while getting the Pfizer COvid-19 vaccine; unsure if she is fully vaccinated or not". The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a health care worker concerning a 20 year old female patient with no pertinent medical history and no drug reactions or allergies reported, who on 02-SEP-2008 was vaccinated with the first dose of GARDASIL (lot # 661044/0548X).  It was reported that on 07-NOV-2008 the patient received her second dose of GARDASIL (lot # 660557/0072X) 0.5 ml intramuscularly, and on the next day, 07-NOV-2008, she experienced nausea, vomiting and diarrhea.  There were no concomitant medications.  The patient sought medical attention at a doctor's office and no lab diagnostic studies were performed.  At the time of the report the patient was recovering.  Additional information has been requested.
Received vaccine at 3:13 PM in pharmacy attached to  Hospital. Within seconds, breathing felt a little strange but thought it was anxiety. I was instructed to wait the full 30 minutes. While waiting, I became unable to catch a full breath and began experiencing stridor, stomach cramps, lost all color and gained a rapid, shallow heartbeat. The nurse was notified and I was handed an Epi-Pen to self administer, which I did around 3:45 PM. My breathing improved in seconds. I went to the ER for observation and was given Benadryl, famatodine, and another medication to help my breathing I don?t remember the name of. I was under observation until 8 PM when I was discharged to my parent.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (strength, dose, frequency and lot # were not reported). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of he several reports from the same reporter. Additional information has been requested.
Large bright red circle with lump in the middle. Was itchy and warm to the touch. Lasted 2-3 days.
Standard achy, headache, chills.  Started 7 hours later, lasting 24 hours.  Difference, significant left armpit lymph node swelling, day 2, not present after first or second vaccine.