chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has hives in different parts of the body, they are very itchy and painfull; they are very itchy and painful; painful; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful). At the time of the report, URTICARIA (Patient has hives in different parts of the body, they are very itchy and painfull), PRURITUS (they are very itchy and painful) and PAIN (painful) had not resolved.            No Concomitant product use was reported.  The patient stated that they got the Moderna covid-19 Booster shot on 07-DEC-2021 and now they had hives in different parts of their body and those were very itchy and painful.   No treatment information was provided.
Gave pediatric patient Hep A for adult. Vaccine was administered at 1030am. Documented my vaccines for the day at end of day and noticed the lot number was not coming up. Thought it was a system error as we had some errors with other vaccines not coming up so entered it manually. Following day I decided to double check the lot numbers on both vaccines and reference the adult one because it seemed odd the lot number wasn't coming up and sure enough I had realized the lot number I had was for the adult one. Notified supervisor of the error.
4 days post vaccination, recipient developed hives on entire body except head area that are painful and severely itchy. The rash lasts for 4 hours or so than subsides for a few hours only to re-surface again. No other symptoms reported. Recipient was seen in the ER, Dermatologist, ENT, and Allergist and put on a steroid tapering dose + antihistamines on 3/24.
On 6/9/00, pt received her 1st Lymerix and subsequently, she had pain and redness at the injection site. Outcome: resolved. On 7/10/00, she had her 2nd shot and on 7/11/00, the pt had "extreme" muscle, joint, bone and skin pain. She is using codeine for sleep. She "may well have had a tick bite" and was started on Vibramycin X 3 weeks, starting on 7/25/00. The pt's husband, who is a doctor, reported that she may have gotten some phlebitis from the tick bite. She no longer had a visible bite mark. She had some calf tenderness, wore a TED, an elastic compression stocking, on that leg, and has been taking Motrin for the pain of Lyme disease. Joint complaints have not been evaluated by a physician. No arthritis lab work was done, or joint fluid obtained. The most recent information, received on 8/1/00, reports the outcome of the event as unresolved.
RASH DEVELOPED OVERNIGHT. FIRST ON ARM, THEN CHEST AND BOTH LEGS.  ADVISED PT TO APPLY HYDROCORTISONE TO AFFECTED AREAS 2 TO 3 TIMES PER DAY  AND TAKE LORATADINE FOR PRURITIS.  PT BREASTFEEDING, SO PT  DID NOT WANT TO TAKE DIPHENHYDRAMINE.
Bloody diarrhoea; diarrhea; nausea; vomiting; fever; minor sore left arm; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea) (seriousness criterion medically significant), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). In March 2021, the patient experienced PAIN IN EXTREMITY (minor sore left arm) and PYREXIA (fever). On 04-Mar-2021, PAIN IN EXTREMITY (minor sore left arm) had resolved. On 15-Mar-2021, PYREXIA (fever) had resolved. On 16-Mar-2021, DIARRHOEA HAEMORRHAGIC (Bloody diarrhoea), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075222 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. -MODERNATX, INC.-MOD-2021-075222:crosslinked to Dose2
12/21 night Headache, pain at injection site, body chills, runny nose. Symptoms gone by next morning. Tested positive for Covid-19 on 12/23.
Client noted left shoulder pain about 5 hours after receiving her first Moderna vaccination. Client states she believed the dose was administered too  high on her arm.  Sx: left shoulder pain; "didn't want to move (her) arm."   *Denies* pain at injection site, redness, swelling, itching or fever.   Client visited her PCP on 3/23/21. Client reports that her PCP thought that the vaccinator likely hit a tendon near client's shoulder. RXed lidocaine patch, ibuprofen, ice, and benadryl.
I mistakenly administered COVID19 Pfizer-BioNTech Bivalent Pediatric Age 5-11 0.2mL (booster only) when the patient should have received COVID19 Pfizer-BioNTech Monovalent Pediatric Age 5-11 0.2mL. This was the patient's first dose. Both vaccines look very similar in an orange and white box, with an orange cap on both vials and bivalent being in very small font. The mother did not mention that the patient had any side effects and was only concerned that her daughter was given the wrong vaccine. I informed the mother that the patient should receive one dose of COVID19 Pfizer-BioNTech Monovalent Pediatric Age 5-11 0.2mL in 3 weeks to complete the primary series. I then informed the mother the patient can receive COVID 19 Pfizer-BioNTech Bivalent Pediatric Age 5-11 0.2mL (booster only) after 2 months. The mother expressed understanding.
Patient reported swelling  at injection site and swelling  extending up to left side of her neck. Patient also reported a small movable lumps located  next to her left collarbone.  Patients reaction was reported on the VAERS website. Patient will be coming in for a follow up visit with provider if reaction is not resolved.
Severe swelling and pain in arm, high fever 103+, immediate dehydration, leg and body cramping, severe body pain, large red welt at injection side, severe headache, blurry vision.
CLOTTING; MPV IS HIGH; This spontaneous report received from a patient via a company representative concerned to patient of unspecified age and gender with unknown race and ethnicity. The patient's weight, height, and medical history were not reported. Patient reported that last year Mean Platelet Volume MPV was in the normal range.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry date were unknown) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the patient performed yearly bloodwork and physical test which showed Mean Platelet Volume (MPV) was high and it lead to clotting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the MPV was high and clotting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210517660-covid-19 vaccine ad26.cov2-MPV was high and clotting. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Booster dose of Moderna given was 0.5ml and should have been 0.25ml
Vaccine expired on 8/31/2022; vaccine administered on 9/6/2022. No known adverse reaction.
Warm feeling bilateral to the legs. Itching to plantar left foot. VS 197/89 HR 114 at 13:38. VS at 13:46 150/78 HR 106. Denies SOB, palpitation, no N/V.
Heart attack; Clots in my coronary arteries; Lot o itching especially on my arms and legs; Skin rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack), CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries), PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) 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 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 30-Mar-2021, the patient experienced PRURITUS (Lot o itching especially on my arms and legs) (seriousness criterion life threatening) and RASH (Skin rashes) (seriousness criterion life threatening). On 28-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and CORONARY ARTERY THROMBOSIS (Clots in my coronary arteries) was resolving and PRURITUS (Lot o itching especially on my arms and legs) and RASH (Skin rashes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Angiogram: clots in findings (abnormal) Clots in coronary arteries.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient was discharged and is continuing the treatment as prescribed. Company comment:Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
By March 9, I began experiencing loss of appetite, tiredness, jaundice and nausea.
Felt like she had the flu; Sinus infection; injection arm hot; It's getting hotter and bigger; injection arm red; fever; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger) and VACCINATION SITE ERYTHEMA (injection arm red) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever). At the time of the report, INFLUENZA (Felt like she had the flu), SINUSITIS (Sinus infection), VACCINATION SITE WARMTH (injection arm hot), VACCINATION SITE SWELLING (It's getting hotter and bigger), VACCINATION SITE ERYTHEMA (injection arm red) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test negative: negative (Negative) negative.         Concomitant medications included pain medication and a medication for chronic angioedema of the intestines.  No treatment medications were reported.  Upon internal review on 04-AUG-2021, the age was corrected to 44 years.   This case was linked to MOD-2021-269267 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received and contain Non-significant information.
Aprox a week after 1st shot I lost partial hearing in left ear and high pitched buzzing.  Is is getting progressively worse.
Side of face and ear is numb; This is a spontaneous report from a non-contactable consumer reported for Patient (reporter's son) that A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced side of face and ear is numb. It was reported by the reporter that she talked to someone earlier about symptoms her son had from the COVID Vaccine. States that his symptoms are not on the list of known symptoms. Caller states that the agent told her she was going to check on some stuff for her and then call her back. She states that she missed the call but was left the listed interaction number on her voicemail. She states that her son's side of face and ear is numb. Caller states that Pfizer just wants personal information. Says that her son already filled out a report online and they check in with him by text every day. She states the agent earlier did not have any information for her as the vaccine was still relatively new. Reporter says that she does not want to go through all the personal information again. States that she is so frustrated that Pfizer doesn't know what is calling this. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt presented to office 3 hrs after administration of varicella vaccine with h/a, nausea, hyperventilation and swelling and redness at site of vaccination.
Information was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Medical history, concurrent conditions, and concomitant medications were not provided. The patient's healthcare provider(s), recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2013, a healthcare provider, at a pharmacy, administered the ZOSTAVAX (lot number, dosage and route of administration not provided) to the patient. On 19-APR-2016, the patient was treated by the patient's healthcare provider at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
No additional AE; temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.  On 31-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose and route were not provided; frequency-5; lot# was T028139 and expiration date was 15-FEB-2022) involved a temperature excursion for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).               The administered dose involved in a temperature excursion at - 58 degree Fahrenheit (F) to 5 degree F (9.5 F) for 0 hours 45 minutes 0 seconds and 11 degree F for 1 hour 0 minutes 0 seconds. There was a previous temperature excursion at 9.5 degree F for 0 hours 45 minutes 0 seconds. It was detected by a data logger.   This is one of the 7 cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA002470: US-009507513-2104USA003267: US-009507513-2104USA002475: US-009507513-2104USA003268: US-009507513-2104USA003265: US-009507513-0503USA00121:
lt thigh area w/3.5cm area of induration, 2+ tenderness;
Skin sensitivity, could I shed to him the virus?; Fever; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of sensitive skin in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sensitive skin, fever and fatigue. On an unknown date, the outcome of the sensitive skin, fever and fatigue were unknown.   It was unknown if the reporter considered the sensitive skin, fever and fatigue to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's Comment: The reporter stated that her boyfriend had skin sensitivity on his back and side with fever, and fatigue. The reporter also mentioned patient was already been vaccinated against shingles Additional Supportive Information: The case had been linked to US2022AMR184538, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2022AMR184538:Same reporter.
fatigue; Headache; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 47-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE. lot number: EK5730), via an unspecified route of administration on 18Dec2020 10:45 in right arm at single dose for COVID-19 immunization. Medical history included Hashimotos thyroid disease and Mitral valve prolapse (MVP) from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) and ferrous glycine sulfate (FE). The patient previously took Reglan iron infusions and experienced allergies. The patient experienced fatigue, headache and nausea on an unspecified date. The patient was not pregnant. The outcome of the event headache was not recovered and the outcome of the remaining events was unknown. The facility where the most recent COVID-19 vaccine was administered was in the hospital.   Other medical history: hashimotos thyroid disease mvp
Extreme arm pain alternating with numbness and tingling, joint pain in shoulder, elbow, and wrist, chills, low grade fever (100.5), fatigue
Had tongue numbness, paralysis for a short period of time today.  Concern for anaphylaxis due to proximity to throat.   Pain around top of head in the shape of a semicircle. Very tired, weak.  Drained.
Received immunization 6/10 AM. Well until 6/18 PM.  Low grade T up to 102.5 on 6/19 & 6/20. 6/19 broke out in fine maculopapular rash on foot-trunk-ext. No oral lesions, no other contact. Seen rash on 6/20 Dx "MMR reaction".
Not feeling well after booster dose; flu like symptoms,Minor flu like symptoms,Mild case of the flu; will feel crappy when she goes to work; Muscles are sore,Minor muscle aches; Minor headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 011A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache). At the time of the report, MALAISE (Not feeling well after booster dose), INFLUENZA LIKE ILLNESS (flu like symptoms,Minor flu like symptoms,Mild case of the flu), FEELING ABNORMAL (will feel crappy when she goes to work), MYALGIA (Muscles are sore,Minor muscle aches) and HEADACHE (Minor headache) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided. The patient stated that the first 2 doses worked beautifully where patient was exposed to someone with covid and was hospitalized but the caller stated that patient was protected after being exposed to that person as patient had received her moderna vaccinations