chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2022 and was forwarded to Moderna on 03-Feb-2022. WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN. The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of THROMBOSIS (Clotting). The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Jan-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Started bleeding/bleeding started 2.5 weeks before my actual period date/all the blood that was coming out/how heavy her period was) and VAGINAL HAEMORRHAGE (Vaginal bleeding). On 02-Feb-2022, the patient experienced THROMBOSIS (Clotting) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Worried). At the time of the report, THROMBOSIS (Clotting), HEAVY MENSTRUAL BLEEDING (Started bleeding/bleeding started 2.5 weeks before my actual period date/all the blood that was coming out/how heavy her period was), VAGINAL HAEMORRHAGE (Vaginal bleeding) and ANXIETY (Worried) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, Pregnancy test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Patient had to go to the doctor because of how heavy her period was. Her appointment is later today 03-Feb-2022. Her last cycle was 18-Jan-2022 to 21-Jan-2022. Patient thought she had a miscarriage because of all the blood that was coming out. Patient wants to know if normal and how long it lasts. The patient confirmed that it was vaginal bleeding. Treatment medication was not provided by the reporter. Company comment: This regulatory authority case concerns a 25-year-old female patient with no reported relevant medical history, who experienced the serious unexpected event of thrombosis approximately 6 days after the last dose of mRNA-1273 (Spikevax). The patient experienced the possible manifestations of heavy menstrual bleeding, vaginal haemorrhage and anxiety. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Sender's Comments: This regulatory authority case concerns a 25-year-old female patient with no reported relevant medical history, who experienced the serious unexpected event of thrombosis approximately 6 days after the last dose of mRNA-1273 (Spikevax). The patient experienced the possible manifestations of heavy menstrual bleeding, vaginal haemorrhage and anxiety. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report.
Swelling/pain at site of injection. Funny taste in mouth.  Nausea, fatigue, feverish, headache, and depressed went home sick and was sick the next day-12/18/2012.
Shot was on top of shoulder, as soon as the needle went in I could feel pain the time I got to my car I could not lift my arm since then it has ached, went to orthopedic surgeon says I have a rotator cuff tear. Surgeon wants to do surgery.
Adverse reaction; second dose on the two month mark; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HAB (Twinrix).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced adverse reaction and drug dose administration interval too long. On an unknown date, the outcome of the adverse reaction and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the adverse reaction to be related to Twinrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received 2nd dose of vaccine later than recoomended interval, which led to lengthening of vaccination schedule. After second dose, the patient experienced adverse reaction and pharmacist wanted to know if this could be avoided by giving patient a third dose separately of Hepatits A (Havrix) and Hepatitis B (Engerix-B) vaccines instead of a combination Twinrix. The reporter consented to follow up. No Batch nor expiration dates for vaccines could be obtained by reporter. For patient no date of birth could be obtained.
Initial side effects were minimal/expected. After about 48 hours I started experiencing jaw pain in the left mandible extending up to the left temporomandibular joint. I have a relatively high pain tolerance so I wouldn't say the pain was severe or life-altering, but since the frameworks reported occurrences of reactogenicity at 3 or greater and I am taking OTC pain medication to manage my jaw pain, I figured it was a data point worth reporting. The pain is certainly tolerable, but makes opening my jaw fully or chewing on the left side unpleasant enough to make it worth taking painkillers.
Mother reported very hard, red, warm and swollen area to left upper arm and fever of >103 degrees F within 3 days after receiving the vaccines.  She did not consult the child's physician until 3/13/09. According to mother the physician did not feel the reaction had been outside of the expected side effects of the vaccines received.
Client has hardness, redness, swelling, warmth, and itching at VARIVAX injection site- right arm.  Client's mother reports area is the size of her hand.  Client seen by her doctor and BENADRYL recommended and ice to site.
Injection site black and blue and warm; Injection site black and blue and warm; Redness extended 6 inches below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Injection site black and blue and warm), VACCINATION SITE WARMTH (Injection site black and blue and warm) and VACCINATION SITE ERYTHEMA (Redness extended 6 inches below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history and concomitant medication was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up information received  contains no new significant information.
tested positive for Coronavirus after both doses of vaccine; tested positive for Coronavirus after both doses of vaccine; Exposed to Covid; This is a spontaneous report from a contactable nurse. This nurse reported for a 78-year-old female patient (reporter's friend). A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and Expiration Date: unknown), dose 2 via an unspecified route of administration on 16Feb2021 and dose 1 via an unspecified route of administration on an unspecified date (Lot number: unknown), both as single dose for COVID-19 immunization. Medical history included pacemaker (got it within the last 3 years for an arrhythmia). There were no concomitant medications. On 18Feb2021, the patient was exposed to COVID and started feeling unwell. On 19Feb2021, the patient was experiencing symptoms. On 22Feb2021, the patient was tested positive for coronavirus after both doses of vaccine. The patient underwent lab tests and procedures which included body height: 5 foot 8 inches or 5 foot 9 inches on an unspecified date and sars-cov-2 test: positive on 22Feb2021. The outcome of the events was unknown. The patient's doctor advised her to have antibody infusion because she didn't tell that she got the vaccine. The reporter did some research and read that it was not advised as the antibodies would compete with each other. The reporter wants to know if the patient should do the antibody infusion after getting the vaccine or not.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, A possible contributory role of the suspect product to the development of the event cannot be excluded.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 21-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.111111111 celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
Numbness and tingling of the face, neck and shoulder; Numbness and tingling of the face, neck and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness and tingling of the face, neck and shoulder) and PARAESTHESIA (Numbness and tingling of the face, neck and shoulder) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002H21A) for COVID-19 vaccination.     No medical history was reported.     On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness and tingling of the face, neck and shoulder) and PARAESTHESIA (Numbness and tingling of the face, neck and shoulder). At the time of the report, HYPOAESTHESIA (Numbness and tingling of the face, neck and shoulder) and PARAESTHESIA (Numbness and tingling of the face, neck and shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
minor tiredness; Circular Rash on upper arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (minor tiredness) and VACCINATION SITE RASH (Circular Rash on upper arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014L6204) for COVID-19 vaccination.     The patient's past medical history included Swelling and Redness.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced FATIGUE (minor tiredness) and VACCINATION SITE RASH (Circular Rash on upper arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 25-Jan-2021, VACCINATION SITE RASH (Circular Rash on upper arm) had resolved. At the time of the report, FATIGUE (minor tiredness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2021: Added Reporter contact details, patient demographics and events were updated.
sore arm, lightheadedness, chest tightness, palpitations, weakness;able to finish work shift & drive home;slept awhile;by next evening feeling better;able to work
administered vaccine that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 16th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reportd by the Medical assistant. The patient was administered with Bexsero prefilled syringe and the reporter then noticed the vaccine had expired, which led to expired vaccine used. The reporter failed to ask if it was dose 1 or dose 2 and also failed to ask if the dose was given intramuscularly.  The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Patient complained of rash mainly on back/abdomen and small amounts all over; complaints of ST, wheezing, chest feeling tight, coughing.
This spontaneous report as received from a nurse refers to a 4 year old male patient. The patient's medical history and concurrent conditions were not reported. On 10-SEP-2012, the patient was vaccinated   with the first dose of (Oka/Merck) VARIVAX (strength, route, anatomical location, lot number and expiration date were not reported). There was no concomitant therapies described On 02-AUG-2015, a second dose of (Oka/Merck) VARIVAX (lot reported L008969, exp date 11-MAR-2017) was administered to the patient. On 14-AUG-2014, reported as 10 days after the vaccination with (Oka/Merck) VARIVAX, the patient experienced rash, which outcome was unknown. The patient contacted the nurse. It was reported that the patient sought medical attention, but he did not receive treatment for the above event. There were not labs performed for this event. The nurse did not assess the rash with (Oka/Merck) VARIVAX. Additional information has been requested. The lot number L008969 is not valid for (Oka/Merck) VARIVAX.
I was really sick for 5 days after the vaccine just like when I had covid and I even had an extra symptom I didn;t have the first time , and since then I have not been able to breath I have no clue if it really is asthma or shortness of breath but I have to use an inhaler a couple of times a day I get out of breath walking a short distance ?
upset stomach with diarrhea; upset stomach with diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Lot number: FK5127) at the age of 8 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: ABDOMINAL DISCOMFORT (non-serious), DIARRHOEA (non-serious) all with onset 18Nov2021, outcome "not recovered" and all described as "upset stomach with diarrhea". Therapeutic measures were not taken as a result of abdominal discomfort, diarrhoea.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for Covid-19. The patient received other medications in two weeks: Zyrtec and flonase spray over the counter. The patient had allergies was none. On 18Nov2021, the patient experienced adverse event:18 hours post first dose of Covid vaccine, 8-year-old female patient has upset stomach with diarrhea. No other symptoms to report. The patient was not received treatment. Outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
J & J vaccine Chills, body aches, joint pain, headache, vomiting
rash around shot area; A spontaneous report was received from a consumer concerning a 77-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash around shot area.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 002A21A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient experienced the event(s) rash around shot area.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash around shot area was unknown.
Incorrect diluent volume was mixed (the vial contents were diluted with a diluent volume of 0.8 mL instead of 1.8 mL), but a 0.3 mL dose was administered. We have already talked to Pfizer-BioNtech. They told us that if the dose given in error is the first dose, a second dose should be administered at the recommended interval of 21 days. If the dose given in error is the second dose, the series is complete, and no additional doses are needed. We have already informed the patients of the  potential for local and systemic adverse events.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (8 to 10 years ago.). On 3rd May 2018, the patient received the 1st dose of SHINGRIX. On 3rd May 2018, less than a day after receiving SHINGRIX, the patient experienced shivering. In May 2018, the patient experienced fever, feeling down and cyst. On an unknown date, the patient experienced sickness. On an unknown date, the outcome of the fever and shivering were recovered/resolved and the outcome of the sickness, feeling down and cyst were unknown. It was unknown if the reporter considered the fever, sickness, feeling down, shivering and cyst to be related to SHINGRIX. Additional details were provided as follows: The patient stated that, in the same night of his shot he was shivering, it resolved after he got in bed and under the covers. Within the next day, the patient had fever of 99.4 degree F and that resolved within 1 to 2 days. The patient also had a cyst on his back the day of the vaccination that he wonders if that could have caused the fever. The patient stated that the pharmacy was requiring the physician's prescription for him to get the 2nd shot due to the fever from the 1st vaccination. The patient stated that he felt sick and didn't feel like doing much.
Headache; Body aches; Feverish; Very weak; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8733), via an unspecified route of administration in the left arm on 28Mar2021 at 12:15 (at the age of 27-years-old), as single dose for COVID-19 immunisation.  Medical history included epilepsy and chronic asthma. The patient did not have any allergies to medications, food or other products. Concomitant medications included leviteracetam (MANUFACTURER UNKNOWN), nitrofurantoin (MANUFACTURER UNKNOWN), CBD (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN) and Vitamin B (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 11:45 (at the age of 27-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 00:00; the patient experienced body aches, feverish, headache and very weak. 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 events. The clinical outcome of the events body aches, feverish, headache, and very weak were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vaccine given to patient 2 weeks before he was 16 years of age.  Pt had no issues with dose.
Eyes swollen, teary.  By afternoon itchiness legs and abd.  On 9/27/13 hives developed, lips swollen.
Felt like I had the flu: headache, mucles aches, joint pain, nausea, weakness, exhaustion, felt feverish but no actual fever. I took Tylenol every 6 hours. It helped my symptoms about an hour after taking the Tylenol then about 5 hours later the symptoms came back. The next day, I felt about 50% better and this evening I'm about 90% better.
The pt experienced induration at injection site for 2 days, fever of 102.9 for 2 days and malaise. Site is warm and tender.
missed second vaccine window / haven't received 2nd dosage what should I do?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?). On 19-Jun-2021, PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. List of concomitant medication were not given.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: NNI
With in 10 min of  getting the vaccine my throat felt was closing and I had difficulty breathing and tongue swelling diaphoresis in and out of consciousness Ent gave me 1st Epi-pen in right arm  called EMS gave me diphenhygramine 50 mg and 2nd Epi-pen and IV albuterol nebulizer treatment and oxygen I think they worked on me for 20 minutes then I went to the hospital and was treated there with meds in IV know I have to carry a Epi-Pen with me at all times
Patient was not eligible for the vaccine. They were under 50 years of age (49 years old) without any immunocompromising conditions.
Redness, soreness, edema at injection site. fever, chills, Myalgia. Taking Advil for discomfort 10/20/2008 9:45am.
pt recvd vax; devel fever,leg pain 16jan95;fever persisted thru 20jan95, reaching 106 at least twice;19jan95 devel erythematous papular rash;
pt recvd vax & devel swelling, redness, absces formation of left deltoid area w/ t 103;