chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; Does not feel well; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and MALAISE (Does not feel well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RASH (Rash) and MALAISE (Does not feel well). At the time of the report, RASH (Rash) and MALAISE (Does not feel well) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.  Concomitant medications was not provided by the reporter. Treatment information was not provided.
Pt c/o SOB, dizziness, inability to breathe & throat swelling w/in 10 min p/shot, VS stable; pt given DPH; cont to c/o throat swelling; pt given epi;
Patient developed hives the next day.  Since 2/5/21, they come and go.  No reaction s/p first dose
pt presented with acute onset of  shortness of breath, phone and severely hypertensive s  and hypoxic requiring BiPAP. tested positive for covid treated with iv antibiotics, steroids and bronchodilator and lasix. pt discharged home once stable.
Within 2-3 hrs post AVA #2 on 05 Jan pt developed hives. Initially started as an itch on abd then proceeded to whelps all over body except face. No other symptoms. Called clinic, took BENADRYL that PM and was see the following AM. Was given a burst of steroids. She continued to have lesions appear before beginning to resolve by day 3-4. Did complete steroids. No new foods, soaps, detergents. No previous reactions to vaccines. Symptoms: hives, pruritus.
Started with coughing and chest congestion. Felt awful but no fever. Tested positive with Covid test at home and again at pharmacy. Started on Paxlovid the afernoon of 6/12/22. Felt better at end of treatment.
Initial unsolicited case received from a healthcare professional on 17 February 2015. An 8-year-old female patient received 5 doses of DAPTACEL (lot number and dates of vaccination not reported) as per immunization schedule, and was subsequently diagnosed in 2014 with pertussis. According to the reporter, the patient had completed the full schedule of doses. The patient was seen in the office on 06 November 2014, and the diagnosis was laboratory-confirmed. Outcome was reported as recovered. Documents held by sender: None.
felt like he was having heart attack/diagnosed with Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included OMEPRAZOLE and LEVOTHYROXINE for an unknown indication.   On 28-Jan-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 09-Apr-2021, the patient experienced PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) (seriousness criteria hospitalization and medically significant). On 09-Apr-2021, PERICARDITIS (felt like he was having heart attack/diagnosed with Pericarditis) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: abnormal (abnormal) Pericarditis.         Treatment medicines include steroids unspecified Action taken with mRNA-1273 in response to the events was not applicable. Company comment: 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. Further information has been requested.; 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. Further information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, Chills/ Fatigue Narrative:  Other Relevant History:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes mellitus" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacture), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "Rebound COVID with worst symptoms than first time, But still mild". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: unknown. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4 hours following vaccine, patient developed a fever of 104 degrees.  Contacted office and was told it wasn't an adverse reaction to the vaccine and to treat it with Tylenol.  They speculated it was a virus.  Fever lasted through the night at 104 degrees and subsided to 101 degrees by the morning.    By that evening the fever was gone and the patient was fine.  No other symptoms.  Very healthy child, it was the only day he missed of school all year.
Pfizer dose drawn up by RN - 0.2 cc from newly opened 5-11 Bivalent Pfizer vial. No diluent was mixed with vaccine, so child received 0.2 cc of undiluted vaccine. Patient's Mom informed of error and she is a Emergency RN and she immediately called Pediatrician Dr. PRIVATE. Dr. and Mom chatted within 10 - 15 minutes of the error. Dr. requested that Mom monitor patient closely and suggested Benadryl and Tylenol (per pkg. instructions) tonight. This RN also instructed Mom to push water tonight and tomorrow and Mom plans to push fluids, closely monitor and provide Benadryl and Tylenol as instructed
Weakness; Extreme soreness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weakness) and VACCINATION SITE PAIN (Extreme soreness) outcome was unknown.            Concomitant medications were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable, reporter didn't provide causality assessment.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received on 24-06-2021 contains reporter's Email address.; 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.
tingling in hands and lightheadedness like drifting off. memory issues and attention issues, seizure-like symptoms both doses.
I received my Pfizer COVID-19 booster on 1/2/2022. On 1/12/2022 or 1/14/2022, I woke up early in the morning with an itch on my right calf. When I turned on the light, I saw there was a painful, itchy rash on my calf. I took pictures of it and emailed them to my doctor, who messaged me back and told me that it looked like shingles. They prescribed me valaciclovir. About a day after the onset, I also had a rash on my left calf. My doctor thought it was a strange presentation of shingles, since only my calves were affected, but since I had pre-existing lupus and had recently received my booster for COVID-19, it wasn't entirely surprising. It took about 2 weeks for my shingles to subside, and during that time, my sores blistered and oozed. On 5/26/2022, I developed an itch on my right calf while I was in bed, and I immediately knew what it was. I went to the doctor later that day, and he told me it was a shingles recurrence and prescribed me valaciclovir. The presentation was exactly the same as it had been before. Both calves were affected, and the sores blistered and oozed. And again, it took about 2 weeks for the shingles to subside. On 12/28/2022, I developed a sore throat and runny nose. They continued on 12/29/2022. On 12/30/2022 at around 12:30PM, I developed a fever. At 1:25PM, my fever was 102, and I started to develop a cough. By 8:40PM, the fever 103.3, and my oxygen level was 92%. On 12/31/2022, my fever was 105.4 at 12:13AM. I took TYLENOL, which brought it down to 103.8. I slept with an ice pack for the rest of the night. When I took a home antigen test at 8:15AM on 12/31/2022, the result was positive. I then went to a pharmacy at 11:45AM to take a PCR test, which ultimately also yielded a positive result. For most of the day, the fever stayed at around 102, even though I took TYLENOL or ADVIL every 4 hours. At 10:00PM, it shot up to 103.7. I woke up at 5:30AM on 1/1/2023, and my temperature was 102.4. I then developed new symptoms that included a migraine on the left side of my head behind my eye, and my left foot and toes became numb and tingly. Both the migraine and leg numbness lasted for the entire day of 1/1/2023. At about 8:00PM that night, my fever dropped to 101. I slept most of the night that night. On 1/2/2023, I had a fever of 101 for almost the entire day. I would take a TYLENOL, which drop the temperature to only 100. When I woke up that morning, I had a migraine affecting both sides of my head that was concentrated behind my eyes, and it lasted all day that day until I went to sleep at about 8:00PM. At the time of this writing, I have no fever, but I still have a cough.
Inadvertently, an individual under the age of 18 was given a Moderna covid vaccination. Patient was not harmed.
Client was given MMRV and Varicella in opposite out thighs. He was supposed to get MMR and Varicella, was given MMRV by mistake.
Symptoms began on 3/12/22 ~12 hours after her second COVID-19 Pfizer vaccine with chills and skin feeling "sensitive". That evening had an elevated temp (below 100F). The next day she felt "fuzzy brained." On 3/14/22 she developed mild headache which worsened then next day spreading from her L head to her R back of head. She felt dizzy that day intermittently.  on 3/15/22 the dizziness began getting worse and headache persistent but more frontal. On 3/17/22 she had more severe dizziness, felt like the world is spinning and was nauseated from it.   Also feels tired and a little lightheaded, no syncope but has felt like might pass out. No blackout or loss of vision. Dizziness is worse with rapid head movement. No change in hearing. Has had pain in L>R ear.  Nausea but no vomiting.
Information has been received from a physician via field representative referring to a 12 years old female patient. In June 2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose and route were unknown). Concomitantly the patient received a dose of TDAP in June 2013, shortly after the vaccination, the patient developed a high fever that lasted for 4 hours (considered as recovered). The causality between GARDASIL and the event was unknown. Additional information has been requested.
After 3 hours of receiving her Covid -19 vaccine dose#1 the patient began experiencing symptoms.  She reports onset of whole body hives, nausea,  and mild chest tightness.  She used her albuterol inhaler x 1.   Later that night  she took her nightly dose of loratidine.   She also had arm swelling and soreness.
Reporter stated pt recvd 1st dose of Recombivax HB  on 14MAY91 w/in 24 hrs devel severe diarrhea & dehydration; Hospitalized for 3 days for treatment & restabilization of diabetes; pt recovered;
exhausted; headache; didn't feel good at all; pain in the back; sore arm/pain in arm; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm/pain in arm). On 17-Mar-2021, the patient experienced MALAISE (didn't feel good at all), BACK PAIN (pain in the back) and HEADACHE (headache). On 18-Mar-2021, the patient experienced FATIGUE (exhausted). On 19-Mar-2021, MALAISE (didn't feel good at all), BACK PAIN (pain in the back), PAIN IN EXTREMITY (sore arm/pain in arm), HEADACHE (headache) and FATIGUE (exhausted) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body temperature: 99.6 (High) increased, 99.6F.         Treatment medications included 1 dose of aspirin earlier in the day and 2 doses of aspirin at night before bed on 17 Mar 2021. and muscle relaxer on 18 Mar 2021. Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-054932 (Patient Link).
Bad reaction with Itching in Lower extremities; Warts; Rash in her lower legs/Rash in her arm (upper and lower); This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Bad reaction with Itching in Lower extremities), SKIN PAPILLOMA (Warts) and RASH (Rash in her lower legs/Rash in her arm (upper and lower)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 024M20A) for COVID-19 vaccination.     No medical history was reported by reporter.  Concomitant products included ATORVASTATIN and CYCLOBENZAPRINE for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (Bad reaction with Itching in Lower extremities), SKIN PAPILLOMA (Warts) and RASH (Rash in her lower legs/Rash in her arm (upper and lower)). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at an unspecified dose and frequency; LORATADINE for Adverse event, at an unspecified dose and frequency; BETAMETHASONE for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at an unspecified dose and frequency; TRIAMTERENE for Adverse event, at an unspecified dose and frequency and HYDROXYZINE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Bad reaction with Itching in Lower extremities) and SKIN PAPILLOMA (Warts) outcome was unknown and RASH (Rash in her lower legs/Rash in her arm (upper and lower)) had not resolved.            It was reported that  She has been to several doctors including a dermatologist and have been prescribed multiple medication    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up received on 23-JUL-2021 contains outcome of the event rash to not recovered/ not resolved. On 27-Jul-2021: Follow up received contains No New Information
11/11/05 shot administered, 11/12/05 pm felt itchy took Benadryl for 24 hours, 11/13/05 lips, face, swollen, blotchy, ED steroids Benadryl, 11/14/05 worse blotches, 11/16/05 PMD Zantac, Zyrtec given, 11/17/05 felt worse saw allergist possible Naprosyn reaction.
After 9 days a red rash appeared around the point of the shot.  It has grown rather than diminished.  Now it is an oval about 4 inches long and about 2 inches wide.   It is at times itchy.
Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.; The vaccine was administered to about 9 to 10 patients before the excursion error was discovered; vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008c21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days). At the time of the report, PRODUCT STORAGE ERROR (Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days.), PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine was administered to about 9 to 10 patients before the excursion error was discovered) and EXPIRED PRODUCT ADMINISTERED (vaccine expired by 1 day/Vaccine administered to about 9 to 10 patients after being stored in refrigerator for 31 days) had resolved.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-207778 (Patient Link).
Pt came in for Japanese encephalitis vaccine #2. Had received #1 on 9/22/15. Did not realize pt came 1 week too early.
Itching on the Right Arm (Injection Site) after First Vaccine; Rash on the Left arm (Injection Site) after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     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 19-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine). On 23-Mar-2021, VACCINATION SITE PRURITUS (Itching on the Right Arm (Injection Site) after First Vaccine) and VACCINATION SITE RASH (Rash on the Left arm (Injection Site) after First Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not specified. No treatment information was provided.   This case was linked to MOD-2021-238125 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow-up received on 25-Jun-2021, updated contact information, site of injection (right arm), deleted event arthralgia, added stop dates for events and outcome for events.(Recovered/Resolved)
severe pain; severe headache.; Skin crawling / painful; This is a spontaneous report from a contactable consumer via Pfizer colleague.   A 60-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on 06Oct2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation. On 06Oct2021, the patient developed severe pain, severe headache and skin crawling / painful. No seriousness criteria were provided. The patient was not treated for the events.  The patient had recovered from the events on unknown date in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Received vaccine around 10:40 am, by 10:50 started to feel dizzy, eyes felt full, dry, tingly, swollen, voice became raspy and throat itched. Received 25 mg Benadryl PO at around 10:55. Face, arms, chest and abdomen developed a fine red itchy rash, tongue swollen and itchy, lips tingling, wheezing, blood pressure elevated, pulse thready given 25 mg PO Benadryl, taken to the Emergency Room, symptoms persisted, stomach hurt became nauseated, received IV solumedrol, Pepcid, IV fluids, nebulized albuterol. Sent home once stable after 3 hours, with instruction to take Benadryl every 4-6 hours fir the next 2 days, albuterol as needed, and prednisone for the next 5 days.