chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            No Concomitant medication was provided.  The patient reported that after the second vaccine dose she developed a rash that was on the same arm but on the opposite side of the injection site. The rash was very hot and approximately 5 by 3.5 inches large. The patient has applied a cold compress, which has helped. The patient reported that after her first vaccine dose she had experienced a slight headache for approximately 10 hours.
No symptoms when having the vaccine until 2 weeks later, when I developed a heavy sort of chest pain on the left side of my chest directly on the area around my heart. The chest pain got worse when I breathed in too deeply and was relieved slightly by leaning forwards. After a couple weeks of my symptoms I told my family about it since it wasn't getting better. We decided to wait it out because of our income. Reaching about mid October, my symptoms were at their peak so I looked into going to a free clinic. I eventually got my first appointment the next month or so, where the doctor told me my blood pressure was abnormally high at around 145 over 90, so I was put on blood pressure medication. The doctor said that should help with my chest pain, but it didn't, so I went back in a month for a follow-up. At the follow-up, the doctor said my blood pressure was lower but that it could be lower so my blood pressure medication was doubled. This didn't help my chest pain either so I went back in a few months to talk with the doctor again, who said that I would need to go to a cardiologist, so I went there after a couple months. The cardiologist asked me all my symptoms and such, and eventually decided I had residual pericarditis due to the Covid vaccine, and she advised me to file this form with the CDC so here I am now, about 3 months after she told me to.
Localized swelling, redness and induration at injection site 24 hrs after and persistent nausea/vomiting 48 hrs after injection that lasted D4 requiring medical consult.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "thalessemia minor" (unspecified if ongoing), notes: thalessemia minor. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: Tested negative 4 days when done then tested positive; (May2022) Positive, notes: Tested negative 4 days when done then tested positive. 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.
Nov 6, 2011 Mother of patient walked into center escorted by employee. Mother stated child "broke out with rash over body after getting vaccines from center". Mother stated she didn't want to fill out a report, "I'll take them to Hospital". VAERS report completed with info from immunization records.
arm was sore for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore for a couple of days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore for a couple of days). At the time of the report, PAIN IN EXTREMITY (arm was sore for a couple of days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.   This case was linked to US-MODERNATX, INC.-MOD-2021-016969, MOD21-081941 (E2B Linked Report). This case was linked to MOD-2021-090440 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-016969: MOD21-081941:
So it began with severe sciatic pain and then it progressed to neuropathy throughout my entire body. I went to the DR on May 25, 2021. It had began the week after my vaccination. My opinion was that the pain was going to go away on it's own, but it did not. I realized this was something that has never happened to me before, that type of pain or neuropathy. I saw DR, he said it was a common occurrence to have reactions to vaccinations and that it was not that uncommon - even though I have never had any type of neurological problems before. Since then, I began on May 25th 2021, I started taking 300mg 3x daily Gabapentin and I made a phone call on 6/18/2021, the medication was increased to 600MG because I was still having breakthroughs of the neuropathy and pain. I am still on the drug, it will run out in the next week or so and I guess my DR is just waiting to see what happens at that point.
"COVID Arm" rash/rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH ("COVID Arm" rash/rash all over body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ("COVID Arm" rash/rash all over body). At the time of the report, RASH ("COVID Arm" rash/rash all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. No concomitant medications were reported.   On an unknown date, approximately three weeks after receiving the first dose of the Moderna COVID-19 vaccine, the patient experienced COVID arm rash that had spread all over the body.
Seen in the Emergency room on 4/29/21 for chest pain and nausea, vomiting, numbness and tingling in feet and hands.  Various tests were performed to rule out a heart attack.  We were told they felt the symptoms were due to side effects of the COVID-19 vaccination.  Told we could go home, if symptoms worsened or persisted to check with our primary or return to the ER if needed.  We returned home, symptoms did worsen, returned to the ER on 4/30/21. PT was admitted to the hospital and eventually diagnosed with Guillain-Barre Syndrome, type AIDP (acute inflammatory demyelinating polyneuropathy), elevated troponin levels, low vitamin B12, and hypertension.  He was hospitalized through 5/11/21 receiving IVIG treatments and then referred to an acute rehabilitation facility through 6/24/2021.  Released to home and receiving in home therapy services currently.
Redness, swelling of arm extending down into left elbow & lower arms, difficulty using  left arm and discomfort
This case was reported by a physician and described the occurrence of persistent crying in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR (non-gsk) and ROTARIX. On 17 January 2014 at 15:00 the subject received unspecified dose of PEDIARIX (unknown details), unspecified dose of ACTHIB (unknown details), unspecified dose of PREVNAR (unknown details), unspecified dose of ROTARIX (oral). At approximately midnight, 18 January 2014, 9 hours after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying. The subject's mother consulted the physician. On the night of 18 January 2014, 1 day after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying (described as "still crying"), feeding disturbance (described as "feedings off"), cough and runny nose. The mother of the subject consulted the physician again and reported to the physician that the subject "only stops crying when they are rocking her." On 19 January 2014, 2 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced fever, runny nose, persistent crying and whining (described as "still crying and whiny"), and coarse rhonchi. The subject was examined by the physician on 19 January 2014. The physician reported that they had "never seen this type of event in 24 years of practice". The physician also reported that he considered "the event to be moderate." Relevant test results included body temperature taken on 19 January 2014 with results of 100.5 degree temperature. The physician reported that on physical examination, he noted coarse rhonchi and also noted that it was "not a good lung exam." At the time of reporting the outcome of the events were unspecified.
Patient called reporting "burning" rash all over legs, abdomen. Describes as red, non-pruritic bumps. Also reports chills.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No drug reactions or allergies were reported. On 10-NOV-2015 the patient was vaccinated with expired dose of (Oka/Merck) VARIVAX (strength, dose frequency and route were not reported) lot # J014229 with expiry date of 08-NOV-2015. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
Patient was transported via ambulance to emergency room after having a seizure per mother.  She had a fever of 103.8 after motrin.
Three days after patient received SHINGRIX, small patch erupted on skin above left breast. Spoke with RN on 8/20/2018 and after describing the site, RN considered it most likely minor contact dermatitis unrelated to vaccination. Patient seen by PCP on 8/22/18 after no improvement w/ skin and eruption continued with itching, redness. PCP stated that likely Shingles and put on Valacyclovir 1 gm 3 times per day. Patient is concerned that she contracted shingles from vaccine and VIS does not state this is a possible side-effect from vaccine. Picture of skin eruption is available.
Body aches, headache, fatigue, fever Soreness and mild headache started within a few hours of the vaccine. The next morning I woke with severe headache, diffuse body aches, and low grade fever (99.3). Mid afternoon body aches resolved but headache progressed to a migraine. I also developed a 101.4 fever. All symptoms resolved overnight.
In addition to the arm pain and disability, and equally disabling were my systemic symptoms which I?ll elaborate as follows: 1. Depressed mood: By that Tuesday evening of the vaccination my mood was so low that I felt like weeping and was having trouble with activities of daily living. This low mood persisted for several days unless I took an anti-inflammatory drug like ibuprofen. I almost never take anti-inflammatories or pain meds but last week I used ibuprofen and extra strength Tylenol fairly regularly because I have adverse reactions to those too; low unrinary output from anti-prostaglandins. My mood would lift within 30 minutes of taking ibuprofen, making me believe the low mood was certainly caused by inflammation: 2. Generalized myalgias and arthralgias; multiple days for 5-6 days after the vaccination; again, ameliorated by ibuprofen: 3. Diarrhea: I had loose frequent stools all week and are just now abating: 4. Headache: several days I had a headache and I almost never have such under usual conditions: 5. Pancreatitis: I had my annual PE scheduled for 2 days ago and my internist drew many labs per usual. I have had sporadic past instances of mild pancreatitis for unknown reasons and so we decided to draw amylase and lipase levels which are elevated, again indicating mild pancreatitis.
pt recvd vax & did not develop a titer p/8wks;The MD reported approx 14 patients;pts assigned WAES95081597 & 95081815 through 95081827
This spontaneous report was received from a health professional refers to an unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, the patients were administered with doses of RECOMBIVAX HB (Lot # L001441, expiry date: 17-AUG-2017) which was exposed to temperatures outside of the recommended range. Concomitant medications were not reported. No adverse experience was reported. This is one of the six reports received from the same source (MARRS # 1506USA011037, 1506USA014024, 1506USA014025, 1506USA014026 and 1506USA014027). Additional information is not expected as the reporter did not wish further contact.
Could not sleep; Got chills around 24 hours post injection; Feels feverish but temp has not gone above 100F; This is a spontaneous report from a contactable consumer, Pfizer colleague. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on 04Oct2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID -19. It was unknown whether the patient did receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient received any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an intramuscular route of administration on an unknown date as a single dose for COVID-19 immunisation and had no adverse events. On 05Oct2021 at 11:00, the patient could not sleep, got chills around 24 hours post injection, felt feverish but temperature has not gone above 100 Fahrenheit (F). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. On 05Oct2021 at 11:00, the patient underwent body temperature test and the result was temperature has not gone above 100 Fahrenheit (unspecified units). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events could not sleep, got chills around 24 hours post injection and feels feverish but temperature has not gone above 100F was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Blisters sore to the touch under my arm and on left breast  Valtrex 1000mg 3x a day for 7 days
pt received 0.5 ml after single J&J dose. pt contacted, lm . waiting for return call
I have alot of trouble walking; I have no balance at all; my lower legs and feet are turning blue and purple; have alot of trouble walking and it is progressively getting alot worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, administration date Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "I have a lot of trouble walking"; BALANCE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "I have no balance at all"; CYANOSIS (non-serious) with onset 2021, outcome "unknown", described as "my lower legs and feet are turning blue and purple"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "have a lot of trouble walking and it is progressively getting a lot worse".  Additional information: Ever since the patient has received 1st covid vaccine at the end of Jun2021. The patient have a lot of trouble walking and it was progressively getting a lot worse. The patient had to hold on to things just to walk or to stay in a standing position. Now the patient had no balance at all. This all began 2 days after the vaccine. Now lower legs and feet are turning blue and purple.  The lot number for vaccine [Manufacture unknown] was not provided and will be requested during follow-up.
pt recvd flu vax 12:00; 4:00PM c/o pain in rt arm;cont to worsen;6PM fainted 4 x for an hour or 1/2; c/o heat, perspired, chills & shakey;better 9PM;rt arm, upper arm red & swollen-hot
pt recvd vax & became limp, unusual breathing, blank stare; EMT stated pt had a febrile sz, treated & observed in ER for 2-3 hrs;
6/22 29-year-old lady who was been referred to us for evaluation and management of what appears to be chronic cholecystitis
Day 1...stiffness in afternoon and chills in the evening. Day 3...Swelling and redness above the elbow at bicep.
Child was given Kinrix, but should have received Tdap.  No adverse reaction noted.  Will need to receive Tdap at age 10-12 years old.
Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 19-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
After the 2nd shot I had some pain shooting through my hands and feet but it went away after a month.  Following the 3rd shot my entire body hurt, not 1 inch was without pain.  Excruciating pain shooting through my hands and feet, feet and hands would get extremely hot.  This happened most often in the evening.  It is not as bad but I still have the symptoms.
we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented) 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)) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In August 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented) to be related. No further causality assessment was provided for NO ADVERSE EVENT (no adverse event).    No treatment medications were reported No concomitant medications were reported  She is calling just to see what vaccine was given to a patient she can not tell if it was monovalent or bivalent so i am transferring her the Lot # is 044C22A Vaccine was given in August 2022 it was the history of the patient so this is an AE because we do not know what was given and it could be potentially the wrong vaccine so we are just reporting to make sure it is documented
pain in all joints; Joint, hand and feet, swelling; Joint, hand and feet, swelling; hands and feet- redness/redness in knees; Rash around body; This case was reported by a nurse via call center representative and described the occurrence of generalized joint pain in a 27-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 9722R, expiry date 20th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 15th October 2022, 2 days after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced generalized joint pain, peripheral swelling, swollen joints, erythema of extremities and generalized rash. On 17th October 2022, the outcome of the generalized rash was recovered/resolved. On an unknown date, the outcome of the generalized joint pain was unknown and the outcome of the peripheral swelling, swollen joints and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the generalized joint pain, peripheral swelling, swollen joints, erythema of extremities and generalized rash to be related to FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-OCT-2022 Reporter's comment: The nurse had reported that the patient was administered with Flulaval on 13 October, 2022 and by 15 October, 2022 had pain in all joints, especially hands and feet- redness and swelling. The patient had experienced swelling and redness in knees, which had gone down but was still present on 17 October, 2022.  The patient had experienced a rash around body, which had resolved. The reporter had consented to follow-up.