chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lichenoid dermatitis/ got very intense; Scratching; Itching; Hives; Rashy looking; This spontaneous case was reported by a consumer and describes the occurrence of LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense), SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Food allergy to peas and fenugreek. Allergy from birth) since February 1942 and Diabetes since 1995. Concomitant products included SIMVASTATIN from 1998 to an unknown date for Cholesterol, INSULIN LISPRO (HUMALOG) from 1999 to an unknown date for Diabetes, TAMSULOSIN from 2001 to an unknown date for Prostatic disorder, LEVOTHYROXINE from 2000 to an unknown date for Thyroid disorder, ACETYLSALICYLIC ACID (ASPRIN) from 1999 to an unknown date, VITAMIN D [VITAMIN D NOS] and COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE] for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-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 LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense), SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking). The patient was treated with Laser therapy for Lichenoid keratosis. At the time of the report, LICHENOID KERATOSIS (Lichenoid dermatitis/ got very intense) had not resolved and SCRATCH (Scratching), PRURITUS (Itching), URTICARIA (Hives) and RASH (Rashy looking) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication include turmeric (1500 mg per day) No treatment medication information was provided Patient's dermatologist attempted a number of different things, everything has sort of helped.  Patient's doctor wrote "the process is not consistent with urticaria". Patient took light treatments at the 26 May 2021 at the rate of 4x per week. Reduced to 2x per week about 3 weeks ago. Results have been positive (only minor itching and not intense).   This case was linked to MOD-2021-251455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received and updated the reporter details, patient initials, medical history, concomitant drugs and treatment information.
Massive PE DVT?s both Legs Massive Fluid around Left Lung Shortness of Breath  Unsteady when trying to stand or walk Extreme tiredness  Loss of Appetite  Listless Cognitive confusion  Runny nose Itchy eyes
tachycardia at night with patient unable to breathe, sore throat, laryngothoracic spasms at night and cough or inability to cough, incident of severe chest pain with dyspnea and jaw pain and slight swelling on the neck - resolved with beta-blockers, avula test  positive
pt had PPSV 23 administerd on 09/10/2015 with no adverse reaction. Pt reports her L arm area of injection swelled to "size of baseball". Applied cold packs and swelling decreased but tenderness still present at site today - 07/01.
Prior to  vaccine, patient stated has fear of needles. After vaccine patient c/o feeling nauseated; patient?s face became pale in color.  Cold compress applied to posterior neck. On-site EMS assumed care. Patient transferred to EMS observation area.
lack of strength in her wrist; she had arm pain; experiencing strong tachyarrhythmia; shortness of breath during night; This spontaneous case was reported by a consumer and describes the occurrence of TACHYARRHYTHMIA (experiencing strong tachyarrhythmia), DYSPNEA (shortness of breath during night), ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot#016B21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and VITAMIN B12 NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced TACHYARRHYTHMIA (experiencing strong tachyarrhythmia) and DYSPNEA (shortness of breath during night). On an unknown date, the patient experienced ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain). At the time of the report, TACHYARRHYTHMIA (experiencing strong tachyarrhythmia) had not resolved and DYSPNEA (shortness of breath during night), ASTHENIA (lack of strength in her wrist) and MYALGIA (she had arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
It was reported that a pt rec'd Menomune A/C/Y/W-135 (lot#UB245AA) and a Fluzone SV '02-'03 (lot #U0926BA) vaccination at 11:25am on 11/14/02. At 12:40pm that same day, a rash developed at the injection site of the L arm with itching. The pt also complained of lightheadedness. Benadryl 25mg was given by mouth. Th pt was monitored for 30 minutes. At 1:15pm, the pt's vital signs were stable and the rash was fading. The pt also denies any itching. the pt was instructed to notify a physician or be seen in ER if reaction became worse. The pt reportedly recovered from this experience and was released. This case is closed.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. The nurse reported on unknown dates improperly stored (temperature excursion) VARIVAX (lot # L001330, expiration 13-JAN-2016; lot # L004655, expiration 11-FEB-2017) (dosage, and route were not reported) had been administered to unspecified patients. No concomitant medication was provided. Number of doses administered was unspecified. At the time of the report, no adverse effects was reported. This is one of several reports that received from the same source. Additional information has been requested.
I woke up with sniffling and lots of drainage. I was also running fever which started as about 99.8. I completed a COVID-19 home test which was positive. I called the doctor and did a walk-in appointment. My doctor called in Paxlovid. My fever was up to 100 degrees, I developed a sore throat and had a relatively bad headache with lots of head congestion. It took about 3 days to feel better. On the 5th day I was feeling better and tested negative for COVID-19.  2 days afterwards my symptoms returned, and I tested again and was positive. The symptoms lasted for about 2 weeks. After that time, I began to test negative again. I am still having issues with being tired and having fatigue.
PATIENT CAME INTO PHARMACY ON 01/14/2021 STATING HER ARM WAS SORE AND SHE HAD A RED AREA THAT HAD GOTTEN BIGGER AND WAS A LITTLE WARM. SHE SAID SHE HAD NO PROBLEM WITH THE FIRST DOSE. SHE HAD NO OTHER SYMPTOMS.
Covid arm big large swollen red rash that is sore and itchy. Got the same thing with my first does in left arm. Both appeared within 24-48 hours. The first shot post 4 weeks and I still have a small mark.
MORNING AFTER INJECT, ONSET OF SEVERE HEADACHE, LITTLE NAUSEA, STUFFY NOSE, SORENESS AND TIGHTNESS IN THE NECK. TOOK PERCOCET(HAD AT HOME) FOR HEADACHE LASTING 10 HRS. PT FINE NOW.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: ER2613), in left arm, on 12Apr2021 as dose 2, single (Lot number: EW0161), in left arm and on 16Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 47 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Fifteen minutes post Moderna COVID vaccine patient felt her lower lip get heavy, and itchy, similar to when she had an allergic reaction to other medications. It resolved spontaneously after 23 minutes.
The initial case was received on 10 May 2010 from a local healthcare professional. A male patient (age not reported) received a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number UF484CA, sanofi pasteur Inc. lot number C3086) on 19 August 2009. The patient had no illness at the time of the vaccination. He had no pre-existing medical conditions or allergies. Concomitant medications included CELEXA 20 mg and an unspecified vitamin supplement. On 03 May 2010 the patient tested positive for pertussis. The symptoms of a severe cough and an "overall feeling of being unwell" began 5-7 days prior to pertussis testing. The patient required a doctor's visit and was treated with Z-PACK. The outcome was recovered. Documents held by sender: None.
Rash on abdomen, neck and rt temple area. ER evaluation. Possible chicken pox post vaccination.
I keep getting these headaches; Neck is stiff; Rash on my neck; Eyes were blurry; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot no: EW0179, Expiration date is unknown) via an un-specified route of administration on 21May2021 at my left arm as a single dose for covid-19 immunisation. The patient's medical history includes Epilepsy, asthma. Concomitant medications includes Lamotrigine, Proair, Symbicort, Alebe (220mg), to treat the Headache. Patient previously took first dose of vaccine BNT162B2 (Lot number: EWO172) on 29Apr2021 on right arm. On 22 may 2021 the patient experienced keep getting these headaches, Neck is stiff, Rash on my neck, Eyes were blurry, Patient stated that yes, I took my 2nd Pfizer shot on 21st and I have been getting headache so I was taking a pain pill and couple hours later it will comes back but it has been a whole week. Okay, my neck is stiff, I keep getting these headaches. I have a rash on my neck that I have been cleaning with alcohol and I put cream on it. It will go away and then instantly come back and yesterday, my eyes were blurry. When paraphrased, consumer stated, "I want both, I want guidance for it because it won't go away. patient was informed about the Pfizer Medical Information for the concern and was provided with the number as option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and 9am to 3 pm from Saturday and Sunday as per EST. When probed for Healthcare professional, Reporter Stated, "A doctor, No, No, I am cook, I am chef". Consumer added, "I keep having the headache, do I go to the ER. Consumer was again informed to contact for the concern. Patient received treatment included Aleve, 220mg, for headache. Outcome of the events was unknown.   Information about Lot/Batch number is obtained. Additional information has been requested.
Pfizer vaccine, shots 1 and 2, one month apart.  2-24-21, and 324-21. I began getting tinnitus in both ears within a week or so after shot one.  It really got annoyingly noticeable in both ears after shot two.  I would consider the after  effects of each dose to be normal...dose 1 felt a little lousy the next day with headache and fatigue but ok after that, dose 2 felt lousy the next day with low grade fever about 100.5.  Felt fine the next day.  Except for the tinnitus.
Soon after MMR vaccine he lost all ability to talk. Could not make noises. Soon started showing signs of austism. Diagnosed with autism at 18 months. Before vaccine he showed no signs and could talk in three word sentences.
inflamed lymph nodes left armpit; headache; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Feb2021 at 14:15 (Lot Number: EN5318, unknown expiration) as dose 2, single at the age of 49 years old for COVID-19 immunisation. Medical history reported as none. No known allergies. No history of COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) on 29Jan2021 at 14:00 in left arm at the age of 49 years old for COVID-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed lymph nodes left armpit and headache on 23Feb2021. The patient did not receive treatment for the events. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about batch number was already obtained.
fatigue; sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (004756). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: A consumer on the other line would like to know whether or not 4th booster shot had virus in it. She received 3 packages from the mail and wanted the consumer to fill out information and return the package; she didn't have any adverse reactions. She had one sore arm from one of the shots and had some fatigue after several hours after the shot as she claims. She would like to take off her name and mailing list. Advise that she would be transferred to Customer Service Center for Pfizer BioNTech Covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was scheduled to get Covid bivalent while at dialysis.  This was administered after looking through records and confirmed that he had not had the bivalent.  Afterwards, we received a call from Sr Living stating that he had his bivalent on 9/28/2022 with his Flu vaccine.  There was nothing documented showing that he had received the bivalent or any covid vaccine on that day.  The flu vaccine was documented but not the bivalent.  The covid should cross into our system.  It was also not listed as being given in the state registry.  The patient received 2 doses less than a month apart.  No adverse reactions as of this afternoon.
Arm was so sore she couldn't move it at all; dizziness; arm was so sore she couldn't move it at all; Headache; nausea; chills; tiredness; Felt feverish; Whole body soreness, but mostly on left side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache) and NAUSEA (nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and PYREXIA (Felt feverish). On an unknown date, the patient experienced MYALGIA (Whole body soreness, but mostly on left side). On 25-Apr-2021, PYREXIA (Felt feverish) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was so sore she couldn't move it at all), DIZZINESS (dizziness), MOBILITY DECREASED (arm was so sore she couldn't move it at all), HEADACHE (Headache), NAUSEA (nausea), CHILLS (chills), FATIGUE (tiredness) and MYALGIA (Whole body soreness, but mostly on left side) had not resolved. Not Provided
pt recvd vax; approx 36 hrs later,devel erythema & edema (12x6cm)at inject site,w/ pain & dec range of motion of lt arm;tx w/ Keflex x 5 days;
Information has been received from an 85 year old female with sulfonamide allergy who in May 2007, was vaccinated with ZOSTAVAX (Oka/Merck). There was no concomitant therapy. In May 2008, a year later, the patient came down with a terrible case of shingles on her eyelids. The patient was still experiencing the nerve pain, and also became anemic and had tests done for that (colonoscopy, endoscopy). The patient also mentioned that VALTREX affected her kidneys. The patient sought medical attention. Additional information has been requested.
Patient got a rash on her shoulders, neck and back approximately 1 hour after receiving vaccine. Patient said she was able to tolerate it while applying calamine lotion. Patient did not require further hospitalization.
Multiple day crippling migraines each day starting after the booster. Never had chronic migraines in the past, currently having two a day that last from an hour to two hours with a pain intensity of 8 or 9 out of 10. I have alerted my regular family doctor of these issues also.
Information regarding PREVNAR was received from a healthcare professional regarding a 13 month old male patient who experienced redness and swelling at the injection site palpable area measuring 4.3 by 5 cm. The patient received the fourth dose on 30 Apr 2010. The patient's concurrent illnesses include hypothyroidism, gastrooesophageal reflux disease, wheezing, trisomy 21 and atrial septal defect with a past history of premature baby. Indication for PREVNAR was immunization. Product was administered on 30 Apr 2010. Dose regimen was "5.0 ml" (parenteral). Concomitant therapy included PREVAICD, Albuterol and Lexoxyl. The patient experienced redness at injection site and swelling at the injection site palpable area measuring 4.3 by 5 cm on 30 Apr 2010. The patient was seen by his physician on 03 May 2010, and the injection site swelling and redness was recovering. It was reported that as of 05 May 2010, the patient's injection site redness was recovering and the swelling had resolved. No additional information was available at the time of this report.
Vaccine name:   Comirnaty 30MCG/0.3 ML INJ PFIZ Local skin reaction, reddened area 8cm by 4 cm left upper arm at injection site.  Area is still the same now 6 weeks after the injection The skin has not broken down but the rash persists.
Red, raised rash looking like bug bites on body and hands. Also fussiness and low grade fever.
This spontaneous report as received from a registered nurse refers to a 60 years old female patient with Meniere's disease and allergy to TOPROL and diltiazem. The patient was vaccinated subcutaneously in the left arm with 0.65 ml ZOSTAVAX (lot # reported as H011333; expiration date 08-SEP-2013) on 25-SEP-2012. No other co-suspects were reported. There were no concomitant medications. The nurse reported that last night, on 26-SEP-2012, the patient developed cellulitis of her left deltoid. She also had nausea and a slight fever. The injection site area had small bumps and nurse said that "it almost looked like she was developing shingles". The patient visited the office and was given FAMVIR and unspecified antibiotic as a treatment. No laboratory diagnostic studies were performed. At the time of the report, the patient had not recovered. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
About 4 hours after the injection I began to feel extremely tired and took a nap for a couple of hours. When I woke up at 5 pm I noticed body aches and chills, and a migraine that would get substantially worse and became throbbing when I would sit up or stand. After taking some Tylenol (300 mg) I thought I was able to walk for small periods or time (aka walk to the bathroom) but I fainted on the way back
Confusion, disorientation, discombobulated, dizzy, nausea, irritability, persistent headache.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VAQTA and M-M-R II (strength, lot number, expiry date, route and dose were not reported for both vaccines), which were improperly stored by exposed to 31.5F for 29 hours. No adverse effects were reported. This is one of several reports received from the same reporter. (Linked to 1501USA012473, 1501USA012474, 1501USA012475, 1501USA012476). Additional information has been requested.
Well marked area of swelling and soreness extending from hip to knee. Tenderness & itching in right leg only. Gave Benadryl
chills; fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145FB) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Sep-2022, the patient experienced CHILLS (chills) (seriousness criterion life threatening), PYREXIA (fever) (seriousness criterion life threatening) and MYALGIA (body aches) (seriousness criterion life threatening). On 20-Sep-2022, CHILLS (chills), PYREXIA (fever) and MYALGIA (body aches) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   On 29-Sep-2023 patient received SPIKEVAX 2023-2024. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2023-743044.   Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2023: Non-significant follow up received.