chrisvoncsefalvay/vaers-outcomes huggingface dataset:
196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No Concomitant medications were provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine  No treatment medications were provided..   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, updated I narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
I had my vaccination on 11/23/2022. I started to experience slight itchy throat and coughing on 04/20/2023. Those symptoms got worse over the next few days and I tested COVID-19 Positive on 04/23/2023. I was prescribed Paxlovid. I presently feel great on 05/25/2023.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Plaque psoriasis, Ulcerative colitis and Rheumatoid arthritis. Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC), Rheumatoid arthritis (MODERATE TO SEVERE) and Ulcerative colitis (MODERATE TO SEVERE). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. and UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. In June 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. No concomitant medications were reported. It was reported that, in June 2022, the patient experienced COVID 19. In 2022, the COVID was resolved. The patient had COVID back. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment drugs were reported. Company Comment: This spontaneous case concerns a 44-year-old female patient, with concurrent medical conditions plaque psoriasis, rheumatoid arthritis, and ulcerative colitis, for which she is taking upadacitinib, who experienced unexpected, non-serious Covid19 after receiving 3 doses of mRNA-1273 on unspecified dates.  It was reported that she had Covid19 which resolved, then had Covid19 back.  Onset latency of the event from time of vaccination could not be determined due to limited information.  Further clinical course, diagnostic evaluation and treatment details were not reported.  The outcome was unknown.  Concomitant use of upadacitinib could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 44-year-old female patient, with concurrent medical conditions plaque psoriasis, rheumatoid arthritis, and ulcerative colitis, for which she is taking upadacitinib, who experienced unexpected, non-serious AESI Covid19 after receiving 3 doses of mRNA-1273 on unspecified dates.  It was reported that she had Covid19 which resolved, then had Covid19 back.  Onset latency of the event from time of vaccination could not be determined due to limited information.  Further clinical course, diagnostic evaluation and treatment details were not reported.  The outcome was unknown.  Concomitant use of upadacitinib could be a confounding factor.  The ongoing Covid19 pandemic could also be a contributory factor.  The benefit risk relationship of mRNA-1273 is not affected by this report.
Itchy  Swollen rash at  Injection site. Random sites of  itchy pox on left arm, neck, back, & upper legs noticed 2 days after vaccination
This spontaneous report as received from a nurse refers to a 10 months 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.
Headache; Tiredness; Slight fever of 37.8 C; Expiry Date of Pfizer covid 19 vaccine: 28Feb2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Oct2021 (Lot number: FH8028, Expiration Date: 28Feb2021) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot EM9810, The caller clarifies and confirms that she did not have any side effects with the first two doses of the Pfizer Covid 19 vaccine.), administration date: 06Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (2nd dose, lot EN6200, The caller clarifies and confirms that she did not have any side effects with the first two doses of the Pfizer Covid 19 vaccine.), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: HEADACHE (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 28Oct2021, outcome "recovering", described as "Tiredness"; PYREXIA (non-serious) with onset 28Oct2021, outcome "not recovered", described as "Slight fever of 37.8 C"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 27Oct2021, outcome "unknown", described as "Expiry Date of Pfizer covid 19 vaccine: 28Feb2021". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache. No follow-up attempts are possible. No further information is expected.
blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm.   The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism.  On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin.   On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    The patient had a sore arm for about a day after the vaccination.  Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound.  The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate  5 milligrams AM and PM and apxaban  two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week.    There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021.  The outcome of the events were considered as unknown.  Follow up: No follow up information received.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
complained of having a head cold x 9 days before arriving to ED, came to ED after 3 days of worsening symptoms including shortness of breath even at rest.
diarrhea; Dizziness; Nausea; vomiting; fever; chills; fatigue; headache; This spontaneous case was reported by an other caregiver and describes the occurrence of DIARRHOEA (diarrhea), DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (vomiting) and PYREXIA (fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 02-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 DIARRHOEA (diarrhea), DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, DIARRHOEA (diarrhea), DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (vomiting), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Cymbalta. Blood pressure medications. Treatment details were not provided.
I was very sick in Dec and went to the hospital but was released.  I started experiencing insomnia and went to the dr and they discovered I had high BP.  I have another doctor's visit scheduled soon.
I had a reaction in the arm when it first started. I was short of breath, coughing, and felt weak. I had major shortness of breath so I was using a cpap machine while I was awake and sleep. I had upper body swelling and bruises on rib cages. My blood vessels distended in chest and shoulder. I have swollen lymph nodes in my neck and collarbone. I wasn't able to lift my arms up. I had pressure in my head and eye balls. I had muscle weakness and fatigue. I couldn't take care of myself like I normally could. I couldn't use my foot. I am still having these same symptoms. I have knots on my neck and shoulder area. I have extreme headaches. I went to the doctors many times and ER. I was prescribed blood thinners.
Bilateral upper arm discomfort and possible synovitis of the hands following SHINGRIX vaccine. She felt fine immediately after other than the expected arm pain. The following day, she noticed that both of her arms were sore. Since then, she has seen pain spread throughout her body. She reports that her feet do not hurt, and she is not having any pain in her head, but otherwise the rest of her body hurts. Yesterday, she noticed that her hands had also become swollen. They feel very stiff. She has never felt like this before. Other than the body aches, she is feeling in her usual state of health. No fevers or chills. No headaches. No vision changes. No sore throat or trouble swallowing. No nasal symptoms. No cold symptoms. No chest pain or shortness of breath. No cough or wheezing. No abdominal pain, nausea, vomiting, or diarrhea. No rashes. Other than her hands, she has not noticed joint swelling elsewhere.
given a vaccine on 26Jul2021, it was undiluted; One of the patient at the pharmacy received an undiluted vaccine as the first dose on 26Jul2021; This is a spontaneous report received from a contactable consumer from a Pfizer-sponsored program. A 26-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on the right arm on 26Jul2021 at 14:45 (Batch/lot number: FA7485; Expiration Date: Oct 2021) at the age of 26-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were unknown. Family medical history relevant to AE(s) was unknown. Relevant tests was none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Investigation assessment was unknown. The report was not related to a study or program. On 26Jul2021, the patient received an undiluted vaccine as the first dose. Reporter wanted to know if the patient need to restart vaccination series or not, and whether the patient would to be have a schedule for the 2nd dose. Reporter was looking for guidance. The reason of the patient taken Pfizer COVID 19 vaccine was unknown. Last time the patient was talked to yesterday, he was still feeling fine, and that was a few hours after the vaccine was given. The events were not required emergency room and physician office. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Had the shot, got shingles 5 years later/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 01-MAR-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shingles shot and got shingles 5 years later.  The reporter stated that he/she was told get shingles shot every 5 years.  The reporter further stated that he/she did not know. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.  Being conservative, the GSK Receipt Date entered was 01-Mar-2023 as this was the oldest date in the source document as date the author published the social media was 2nd Mar 2023.
Two: 1.  Extreme extreme pain in r arm from injection.   Pt could not function.   Had to cancel work for rest of week.  2.  Became sick from vaccine.  Vomited a series of six times after a few sips of tea.   Later a few other sips of tea and vomited 9 times.  Could not retain fluids.
Information has been received from a registered nurse (R.N.) concerning a 21-week-old female with no medical history or allergies who on 12-JUL-2007, 28-SEP-2007 and 20-NOV-2007 was vaccinated orally with her first, second and third dose of Rotateq (lot# 656393/0240U, 657520/0670U, and 657669/1393U), respectively. There was no concomitant medication. After the second dose of Rotateq the patient developed loose, liquid stools 3-4 times a day on 28-SEP-2007. The patient's parents called the physician's office and reported that no blood was noted. It was reported that the patient recovered and received the third vaccination. No problems were noted with the first or third vaccinations. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2008. Additional information has been received indicating that the "child is fine. Had no blood in stool." Additional information is not expected.
Temp 100.8 Muscle aches headache sore throat sinus drainage fatigue sore arm lasted 2 days.  Sore throat and sinus drainage lasted 3 days.  Rest, fluids, Tylenol. Stayed home.
patient experienced swollen , itchy , feverish  , bruised  arm. she went to her dr.  and the Dr. prescribed an antibiotic for the patient to take
Left arm was throbbing; Fever of 100 degrees F; Headache; Shooting pains in neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Shooting pains in neck), VACCINATION SITE PAIN (Left arm was throbbing), PYREXIA (Fever of 100 degrees F) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0UIB21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 28-Dec-2020.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced NECK PAIN (Shooting pains in neck). On an unknown date, the patient experienced VACCINATION SITE PAIN (Left arm was throbbing), PYREXIA (Fever of 100 degrees F) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Shooting pains in neck), VACCINATION SITE PAIN (Left arm was throbbing), PYREXIA (Fever of 100 degrees F) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, SARS-CoV-2 test: covid positive (Positive) Tested positive for COVID-19. On 17-Mar-2021, Body temperature: 100 (High) Fever of 100 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
chills, nausea, flu-like symptoms after first Shingrix vac. in May 2019; second vac.(12/19) reaction worse than first. Symptoms more acute. My concern: can the vaccine be reformulated to eliminate such extreme reactions. The reactions were listed in the information I received from the pharmacist, however, it is not acceptable to subject people to these adverse reactions. "It's better than getting shingles," is not an illuminating response.
A day after receiving my second moderna, I developed general body aches, headaches and three days later I became disoriented and I got lost when I was going to my brother's house. I also got disoriented on the fourth day and I got lost in my own neighborhood, I could find a way to my home in the neighborhood that I have lived in it for 20 years.  I still have headache upto this minute with foggy brain.
my lips to loose all the skin still suffering from this with my lips not being ab; instantly had an allergic reaction; rashes all over my body; This spontaneous case was reported by a pharmacist and describes the occurrence of CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body) 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.    In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body). At the time of the report, CHAPPED LIPS (my lips to loose all the skin still suffering from this with my lips not being ab), HYPERSENSITIVITY (instantly had an allergic reaction) and RASH (rashes all over my body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided.  Patient got the second dose of the Moderna vaccine in September, and instantly had an allergic reaction which resulted in rashes all over body and patient's lips to loose all then skin. Nowin April patient was still suffering from this with lips not being ab.  No treatment medication information provided.
This case was reported by a nurse via sales rep and described the occurrence of puncture wound in a adult female patient who received ROTARIX. On 17th November 2014 10:30, the patient received ROTARIX. On 17th November 2014 10:30, during the preparation of the vaccine of ROTARIX, the patient experienced puncture wound. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the puncture wound and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the puncture wound to be related to ROTARIX. Additional information received on 17 November 2014: When the patient was opening the bag of transfer adapters, she was pierced by one of the adapters (puncture of hand by transfer adapter of ROTARIX). This case was associated to a product complaint.
Received 4 year old shots on 8/26/08. Got DTaP and IPV in left thigh, MMR and VARIVAX in right thigh. That evening began to get some bumps on left thigh. By 8/28 very itchy pink raised papules, about 6cm around, on left thigh (Hives)
Case number PHEH2011US01537 is an initial spontaneous report received from health care professional on 10 Aug 2011. This report refers to an 18 years old female patient. She was vaccinated with Menveo on 10 Aug 2011. But, Menveo administrated to the patient has undergone temperature excursion of 67 degrees F for up to 10 hours. No adverse reaction was reported.
** 14 weeks pregnant, Due date August 2021.  third pregnancy  I had fever, body aches, joint pain and headache that would not go away even with Tylenol. This lasted for about 7 hours, by 7 am the next morning everything went away expect the headache.  I was just tired.