chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had nexplanton inserted in February of 2021. I did not have a period for six months.  When I received the first moderna vaccine, I had a very light period for a week. One week after that cycle, I had a second period. Since then, I have had three more periods, all heavier than the one before. After research, I found that other woman have had this happen and felt it important to report it.
covid vaccine breakthrough case  dose 1 3/12/21  Moderna 044A21A dose 2 4/9/21 Moderna  018B21A
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated (Oka/Merck) VARIVAX dose 1, (dose, lot # and expiry date unknown). On 05-MAR-2012, the patient received improperly stored (Oka/Merck) VARIVAX dose 2, from lot # 669842/0931AA, expiry date 13-JUN-2013 (dose, vaccination site, route unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Incident details: Per Dr. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand."- The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr.  email. Pt was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also monovalent and bivalent are new terms that have not previously been used when discussing booster vaccines. Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS.
rashes on the arm; rashes turned to blisters that dried up; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rashes on the arm) and BLISTER (rashes turned to blisters that dried up) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rashes on the arm) and BLISTER (rashes turned to blisters that dried up). At the time of the report, RASH (rashes on the arm) and BLISTER (rashes turned to blisters that dried up) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported No treatment information was provided
Office visit notes from provider of 11/18/14:  History:  Onset: 4 days ago.  It occurs intermittently and is improving. Location: left upper arm. The pain is aching. Associated symptoms include swelling. Additional information: pain just with movement, no med taken. Had Tdap injection in Saturday after cutting hand in can lid. Had injection around 6 pm in Saturday  sx of pain and swelling in L arm started Sunday PM, Monday noticed pain radiated to neck  was stiff. Is feeling much better today, sx seem to be resolving. Assessment: Arthus reaction. Reviewed symptomatic treatment measures and emergency precautions reviewed, may take OTC ibuprofen 2 tablets three time daily. I called on 11/26/14 and was told left upper shoulder/neck area fully resolved by the weekend (22nd).
Pt recvd 1st dose of Recomb on 25OCT90 & devel local rxn;
On 01/28/2021, around 9pm started feeling mild tremors, no fever, left arm sore. Today 01/29/20/21, the tremors persisting, they are mild involuntary not painful, able to walk or do my activities at home. I am retired due my condition of PTCL, now on remission.
Report of chills, body aches,  HA, fever and fatigue. Treatment: Alternate between Tylenol and Ibuprofen. Outcome: Symptoms resolved  and did not interfere with ADLs.
Seizure; This case was received via FDA VAERS (Reference number: 1284289) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  Action taken with respect to mRNA-1273 was not applicable.  Very limited information regarding the event have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding the event have been provided at this time. No further information is expected.
no additional information provided/ the pregnant patient did not have a clinical adverse event; a pregnant patient was administered a third dose of VARlVAX on 5 JAN 2022; a pregnant patient was administered a third dose of VARlVAX on 5 JAN 2022; This spontaneous prospective pregnancy report has been received from a physician referring to a 23-year-old female patient. The patient's pertinent medical history was not reported. There were no known drug allergies. Historical vaccine included varicella virus vaccine live (Oka/Merck) (VARIVAX). Concomitant vaccine included flu vaccine.  On 05-JAN-2022, the pregnant patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 mL (lot# U008180, expiration date 12-MAR-2023; strength was not reported) and sterile diluent (strength, dose, lot#, and expiration date were not reported) subcutaneously for prophylaxis (exposure during pregnancy, contraindicated product administered). The reporter stated that the patient was in her second trimester but could not provide any further details on pregnancy gestation. The last menstrual period (LMP) and estimated due date (EDD) were not known. It was reported that the patient was required to be vaccinated in order to obtain an immigration medical clearance. The patient had not sought medical attention. No treatment was given. No additional information or adverse event (AE) was reported. The patient did not have a clinical AE.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 01-JUN-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K006191 expiry date: 02-FEB-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
Extremely early menstrual cycle, day 18,  Regular cycle lasting 45+ days at this age.
Patient received 1st of Pfizer COVID vaccine on 2.3.2021. Approximately 30 minutes after receiving the vaccine, the patient experienced dizziness that lasted around 1.5 hours. Patient also reports experiencing expected side effects such as fatigue, headache, and muscle pain. Symptoms have resolved.
This spontaneous report as received from a physician refers to unspecified patients of unknown age. The reporter stated that in the past, unknown number of patients came into the office to receive the second dose of GARDASIL (lot#unknown) later than the recommended schedule. He did not have a specific patient. No adverse effect reported. No other co-suspects were reported. No concomitant medications were reported. It was unknown if the patients had sought medical attention. Additional information has been requested.
Diarrhea starting 02/17/2023 headache and nausea, after a few days I felt better than reoccurred 02/21/2023. Continues until 02/23/2023. Starting coughing and high fever diarrhea and chills came back, coughing and diarrhea continued until 02/27/2023. Started having green flehm with stuffy nose, reached out to telemedicine 03/01/2023, went to see doctor after telemedicine suggested I might have pneumonia, chest x-ray was needed. Tested for influenza and COVID 03/01/2023.
Passed out immediately after giving MMR, HBV, PPD. Had one tonic-clonic seizure, pale, urinated. Lasted less than 1 minute and recovered spontaneously. Sent to ER for evaluation.
The Pt came in to Rx on 10/30/18 to ask if it was normal for both of him and his wife feeling shoulder pain and could not lift up the arm after the vaccination. The Pt could not remember exactly if the RPh was standing or squade down when administering the vaccine. He did remembered that the RPh asked him if he was toughing up his muscle because she really needed to push hard to complete the injection. The Pt felt pain on the arm and could not fall asleep that night. He took OTC ibuprofen and used heat pads and ice bags. It had been 5 days, but he was not getting better. So the Pt came in Rx to ask. At Rx the Pt was observed that he could not lift up the arm to 90 degree, and no side movement of the arm. When following up with the Pt on the phone later, the Pt stated that he used Ibuprofen for 3 days till Sunday. The following-up RPh advised the Pt to talk with the wife and they needed to find a way to get their arm function back first. An incident report was filed internally on 10/31/2018.
Both kidneys felt like they weighed 10+ pounds each. I experienced dull pain which was constant. It was not an issue if I sat or laid down however when I would stand up it would appear.
Came in to get vaccinations. Received 5 vaccines no problems noted in room when left to pay cashier after few minutes fainted in hallway-ck'ed client-monitored v/s. B/P 1115am 102/42; 1125am 108/60 P 68 assisted to waiting room.
headache; fever; shakes; feeling cold; They said they woke up in bed and were hot; experienced slight discomfort; due to overeating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "anxiety" (unspecified if ongoing), notes: anxiety, others unknown, see previous AE for loose bone in foot/leg; "gastrointestinal issues" (unspecified if ongoing), notes: that in general nerves can manifest via gastrointestinal issues sometimes for her.; "suicidal tendencies." (unspecified if ongoing), notes: anxiety medication that she was on at the time, since it was causing a side effect of suicidal tendencies. The patient's concomitant medications were not reported. Past drug history included: Lavender, others unknown, reaction(s): "Known allergies: lavender", notes: Known allergies: lavender, others unknown. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "headache"; PYREXIA (non-serious), outcome "recovered", described as "fever"; TREMOR (non-serious), outcome "recovered", described as "shakes"; FEELING COLD (non-serious), outcome "recovered", described as "feeling cold"; FEELING HOT (non-serious), outcome "recovered", described as "They said they woke up in bed and were hot"; DISCOMFORT (non-serious) with onset 26Jan2022, outcome "unknown", described as "experienced slight discomfort"; EATING DISORDER (non-serious) with onset 26Jan2022, outcome "unknown", described as "due to overeating".  The lot number for bnt162b2 was not provided and will be requested during follow up.
After my 2nd Pfizer COVID 19 vaccine on 4/5/21, I experienced severe hip pain on both sides about 2 hours after vaccine. On 4/7/21, 5pm I had abnormal light vaginal blood spotting, not as heavy as 3/16/21 after 1st dose. On 4/7/21, I still have hip pain and I'm taking 1 OTC Ibuprofen every 6-8 hours (4/6 and 4/7).  Note: I took 3 extra strength Tylenol on 4/5/21. I am post-menopausal and have not had my period for about 10 years.  I also submitted a report today to document the adverse event, treatment, and outcome(s) after my 1st Pfizer COVID 19 vaccine that I got on 3/15/21.
This spontaneous report as received from a physician refers to a 80 years old female patient. The patient was vaccinated on April 2012 with 0.65 mL dose of subcutaneous injection of ZOSTAVAX, broke out on 17-OCT-2012 into a rash and was diagnosed with shingles. The patient received treatment with acyclovir. The patient sought unspecified medical attention. The outcome of the event was unknown. The relatedness of the event with subcutaneous injection of ZOSTAVAX was unknown. Additional information has been requested.
patient may have received a dose / that was incorrectly reconstituted with sterile water; patient may have received a dose / that was incorrectly reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 10-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st July 2022) for prophylaxis.   On 17th May 2021, the patient received the 1st dose of Menveo. On 17th May 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received menveo which was incorrectly reconstituted with sterile water which led wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No symptoms reported. The reporter mentioned that, they were 3 possible patients but the HCP was not sure which 2 received the incorrectly reconstituted doses. The batch number was reported as AMXA379A for Menveo which was updated to AMVA379A as per sales data sheet. The reporter consented to follow up. This case was linked case US2021111533 and US2021111534,  reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021111534:Same Reporter US-GLAXOSMITHKLINE-US2021111533:Same Reporter
FELT DIZZY AND FELL ON THE FLOOR, HAS NOT EATEN PRIOR TO VACCINE, BP: 135/98, HR 94. PT WAS INSTRUCTED TO F/U WITH PCP. REFUSED TRANSPORT.
Right afterwards, I had soreness of arm for several days. Like someone punched me in the arm. (Injection site arm.) This lasted for days. I didn't have a fever or anything else. Last week in July - I started getting a rash/eczema condition. It started in hands and it went up my wrist and went up my upper arms and it's scaly and then it started on my legs and going up my legs, too. It gets worse at time and then it gets somewhat better and then gets worse again. It hasn't gone away though since it started.  It's itchy and scaly. I am putting an eczema cream (cortisone) on it and I have an ant-itch spray that I spray at night sometimes. Because sometimes my ankles and lower legs start itching really bad and it's hard to sleep. These help a little to relieve that. Dermatologist  - waiting on my referral approval that visit. Should get it this week. My doctor has looked at it.  Note: About 6 weeks after the second vaccine, I had the first Shingles vaccine and then in the timeframe  required after that I had the 2nd Shingles vaccine. My rash/eczema symptoms didn't show up until after those vaccines.
Narrative:  63 YO F with PMHx significant for PTSD, depression, HLD, obesity,  hypothyroidism, and migraines reported headache for ~1 week after 2nd COVID- 19 vaccination. Per recent PCP note, patient's headache have been controlled on current headache regimen (topiramate 100mg QAM and 200mg QPM+ sumatriptan 50mg prn). Patient did not seek medical assistance for reported sx.
Muscle and Joint aches, upset stomach, mild loss of balance, temperature 102.4, Pain at injection site. Lasted for 48hrs
PATIENT STATES HER EYES STARTED WATERING AND GETTING CRUSTY AT NIGHT.  SHE WOKE UP NEXT DAY WITH SWOLLEN EYELIDS
3PM 20SEP97 pt ran T105 @ home;mom called MD told to take pt to hosp;was not feeling good 18SEP97 c/o stomachache;
Inflammation in multiple joints of the body.  I have been on steroids, anti-inflammatories, and pain medications.
This spontaneous report as received from a father reporting on his 11 years old daughter. She had no pertinent medical history and no drug reactions or allergies. The patient was prepubescent. On 16-APR-2015 the patient was vaccinated with the first dose of GARDASIL or GARDASIL 9 (dose, route, lot # not provided). The reporter was not sure which vaccine it was and stated that his daughter was vaccinated "because MERCK pushed the doctor into telling that his daughter need it". On 19-APR-2015 the patient experienced vaginal bleeding and was tired after vaccination. The patient did not seek medical attention and there was no treatment given and no lab diagnostic studies were performed. By the time of the report the patient did not recovered from the events. Relatedness between the events and suspect vaccines was not specified. Additional information has been requested.
No additional AE reported; Expired product administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 22-NOV-2021 the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # S035355 and expiration date provided as 05-NOV-2021),0.5 milliliter for prophylaxis (expired product administered). No additional AE and PQC reported.
Fever; Headache; Chills; This case was reported by a consumer via call center representative and described the occurrence of fever in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2020, no adverse events reported).   On 11th November 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, headache and chills. On an unknown date, the outcome of the fever, headache and chills were unknown.   It was unknown if the reporter considered the fever, headache and chills to be related to Shingrix.  Additional information was provided as follows: The patient experienced fever, headache and chills after receiving the 2nd dose of Shingrix. The reporter did not consent to follow up.
Information has been received from a registered nurse (RN) concerning a 9-week-old female who on 08-AUG-2006 was vaccinated by mouth with the first 2.0 mL dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot #653981/0411F). Concomitant vaccinations administered on the same day included a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine inactivated (unspecified), a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine and a dose of pneumococcal 46B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). The RN reported that on 11-AUG-2005 the patient experienced a fever of 100.5 F that was "on and off". On 15-aug-2005, the patient started vomiting "chunky pieces". As of 15-AUG-2006, the patient's vomiting persisted and she still had an "on and off" fever of 100.5 F.  This is in follow-up to report(s) previously submitted on 9/8/2006. Follow-up information was received from the RN who reported the patient did not have any "out of the ordinary reactions". The RN indicated that the patient was not vomiting for a week, but was spitting up for a day and her temperature was a low-grade immunization temperature. The patient subsequently recovered. Additional information has been requested.
exhausted; tingling in my lungs; freezing cold metal sensation in my throat; tachycardia; discomfort / uncomfortable; aching in my chest; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PARACETAMOL (TYLENOL 8 HOUR) and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021 at 11:00 PM, the patient experienced PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable) and CHEST PAIN (aching in my chest). On 05-Jan-2021, the patient experienced FATIGUE (exhausted). In January 2021, PARAESTHESIA (tingling in my lungs), FEELING COLD (freezing cold metal sensation in my throat), TACHYCARDIA (tachycardia), DISCOMFORT (discomfort / uncomfortable), CHEST PAIN (aching in my chest) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Heart rate: increased (High) heart rate was in the 120s, 130s. On 05-Jan-2021, Chest X-ray: negative (Negative) Negative. On 05-Jan-2021, Electrocardiogram: abnormal (abnormal) tachycardia of 120 and some PVCs. On 11-Mar-2021, Serology test: abnormal (abnormal) had great titers. In 2021, Blood immunoglobulin G: positive (Positive) strongly positive. In 2021, Heart rate: high (High) remained elevated whether walking her dog, up and down the stairs, laying down and getting up, lasted for 5 days. In September 2021, Echocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication reported.
I felt like i had a stuffy nose on friday, I took some Flonase on saturday so i could breathe a little better. By saturday night came i had a cough going on. I did an at home test and it was positive.  I notified my company and have been off for 5 days.