chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot to the touch; It is really tender; there was a red area on the arm by injection site and then it came back this morning; red area on the arm by injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender), VACCINATION SITE ERYTHEMA (red area on the arm by injection site) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning) 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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (red area on the arm by injection site). On 16-Apr-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning). The patient was treated with HYDROCORTISONE on 12-Apr-2021 at an unspecified dose and frequency. On 12-Apr-2021, VACCINATION SITE ERYTHEMA (red area on the arm by injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (hot to the touch), VACCINATION SITE PAIN (It is really tender) and VACCINATION SITE ERYTHEMA (there was a red area on the arm by injection site and then it came back this morning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication included beta blocker, not specified.  On 12-APR-2021, the patient had experienced red area on the arm by injection site. The event had resolved and had returned on 16-APR-2021 and was three times as bad. It went from the size of a golf ball to the size of a grapefruit. The redness is red on the outside with a white spot in the center. It looks like a spider bite. It was really tender and hot to the touch. It looks like cellulitis. She went to the ER due to it coming back worse than the first time. She also mentioned that she is on a beta blocker and wonders if that has something to do with her symptoms. She used hydrocortisone for symptoms.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
she developed redness and swelling on the hand of the arm that received the Pneumovax; she developed redness and swelling on the hand of the arm that received the Pneumovax; This spontaneous report was received from a 67-year-old female patient, who was reporting on herself. The patient's pertinent medical history included high blood pressure and high cholesterol. She had no drug reactions or allergies. The patient's concomitant medications included olmesartan and atorvastatin.  On approximately 09-MAY-2019, reported as about two weeks ago, the patient was vaccinated with of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, intramuscularly in an unspecified arm (exact dose, site of administration, lot number and expiration date were not reported) to prevent pneumococcal infection.   On the same night as the date of the vaccination, the patient developed redness and swelling on the hand of the arm that received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection. The patient went to see a pharmacist and received an unspecified treatment. No lab diagnostics or studies were performed. The patient reported that it took her 10 days to recover (exact recovery date was not reported).  The causality between the events and the suspect vaccine was not reported.
Tingling; felt itchy; swelling of the lips; This is a spontaneous report from a contactable healthcare professional. A 31-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), via an unspecified route of administration in the left arm on 09Jan2021 09:30 at single dose for COVID-19 immunisation. Medical history included COVID-19 (prior to vaccination), penicllin allergy, and shrimp allergy. Concomitant medications included cetirizine, fexofenadine and triamcinolone. On 09Jan2021 11:00. the patient experienced tingling, felt itchy and experienced swelling of the lips. Therapeutic measures were taken as a result of the events that include Benadryl and famotidine. Clinical outcome of the events was recovered on an unspecified date.
Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 26-MAY-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored. Concomitant therapies included sterile diluent (lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008451: US-009507513-1707USA008452: US-009507513-1707USA008453: US-009507513-1707USA008454: US-009507513-1707USA008455.
Rash on front of body waist to lower chest. Pt reported event to us on 04/26/2018.
Lose his strength; Difficulty sleeping due to pain; Difficult to walk and get out of bed; Very little appetite; Muscle aches and pains; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Lose his strength), INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included Drug resistance (Not responding to medicines or medicines making him sick.). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), PARACETAMOL (TYLENOL) and LOVASTATIN for an unknown indication.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ASTHENIA (Lose his strength). 15-Mar-2021, the patient experienced INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains). At the time of the report, ASTHENIA (Lose his strength), INSOMNIA (Difficulty sleeping due to pain), GAIT DISTURBANCE (Difficult to walk and get out of bed), DECREASED APPETITE (Very little appetite) and MYALGIA (Muscle aches and pains) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       .Concomitant medication including antifungal for toenail fungus was reported. Treatment using couple of shots that provided by the HCP that did not helped  was reported.
Within 5-10 minutes of injection initial sense of fullness in throat, throat clearing, mild difficulty swallowing. No visible swelling. At 35 minutes after injection attempted to drink water, difficulty swallowing, coughing, no visible swelling. At 45-50 minutes post vaccine  attempted to eat dinner (black beans and rice) difficulty swallowing, coughing. Again no visible swelling. Took Benadryl waited 15 minutes, able to eat dinner - resolved  Other not resolved: Left arm pain referring up to neck and generalized swelling (loose shirt sleeve on Right is snug over left arm) , itchy ears
Marked irritablity started Ga, after vaccination lasted 4 hours; inconsolable for 1 hr.
Information has been received from a physician concerning a 38 year old female with no medical history or drug allergies who was intramuscularly vaccinated with the first, second and third 0.5 ml doses of GARDASIL (1st and 2nd lots #"0770X", 3rd lot #0573X) on 07-AUG-2008, 11-SEP-2008 and 03-FEB-2009, respectively.  The patient developed reactivation of genital warts a few days after receiving her third dose of GARDASIL.  She had negative culture for herpes.  Subsequently, the patient recovered from reactivation of genital warts on an unspecified date.  The patient visited family physician for medical attention.  Additional information has been requested.
12:15 PM Went outside walking up steep steps, noticed shortness of breath, continued to get worse, began coughing, felt irritation in throat, chest tightness, not getting enough air. Eyes started getting red. 3:15 PM continued to feel funny left meeting early and went to E.R.  Never had flu vaccine before. No other vaccine given or in last 4 weeks. No medications taken day of vaccine.
severe vertigo; This is a spontaneous report from a contactable consumer. An unspecified aged female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: unknown) via an unspecified route of administration on unspecified date, as single dose for COVID-19 immunisation. Medical history was not reported, unknown if allergic to medications, food, or other products. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, it was not known whether the patient been tested for COVID-19. It was not known whether the patient had received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced severe vertigo after receiving the first dose of the vaccine to the point where she had to lay down for several hours in Jan2021. it was not known if patient received any treatment for vertigo. The clinical outcome of Severe Vertigo was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: Added Race Information; removed one duplicated indication of SD; treatment received was selected as Unk and the leading sentence and final sentence was updated.
Left elevated arm - x lrg amt cellulitis, Sta A minor - notice upon waking, elevated thru day.
swelling, redness, induration lt upper 1/2 arm; hurts to move;
got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive; got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he is a physician and got COVID vaccine from Pfizer, next day got COVID tested with mild symptoms and positive. The patient stated so he got vaccinated probably while having COVID. The patient wanted to know any concerns from the vaccine standpoint efficacy side effects. Outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Left arm with large local reaction, erythema, warmth, extending 2-3 cm up to 10cm inferior to injection site left deltoid.
redness at injection site; swelling at injection site; lump at injection site; Full body rash (from head to toe).; Rash looks a little like chickenpox; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 5th September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site lump, generalized rash and varicella. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site lump, generalized rash and varicella were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site lump, generalized rash and varicella to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the patient experienced redness, swelling and a lump at the injection site. The patient also experienced full body rash (from head to toe). The reporter stated that the rash looked a little like chickenpox. The patient was taking over the counter Tylenol and Benadryl for the symptoms. The emergency room visit was required. The reporter did not provide any additional information.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 16-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J013316, expiration date: 20-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner concerning her 5 year and 6 month old niece who on 17-DEC-2010 was vaccinated with the second dose of VARIVAX (Merck) (Lot #, expire date and route not reported), 0.5 ml. Nurse practitioner reported that two months and a week after her niece completed her therapy with VARIVAX (Merck) on approximately 24-FEB-2011, her niece developed a shingles type rash on her chest. The patient was then taken to a pediatrician's office and it was confirmed that she had shingles. At the time of the report, the patient was recovering. Additional information has been requested.
pt recv vax & 17NOV96 exp itching, soreness, swelling from shoulder to elbow;18NOV96 pt exp a rash extending to back, chest, & face;ER or MD visit was required;19NOV96 tx w/DPH;
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 80-year-old female patient who received SHINGRIX for prophylaxis. On 15th May 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 16th May 2018, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient had her shot of SHINGRIX in the left arm in the morning. The patient felt soreness at the injection site. The next day she had pain in her arm and could not raise it. In May 2018, the pain and soreness lasted approximately for 24 hours. For tolerance to next dose, refer case US2018GSK150386.
102 Fever, body aches, flush, chills, headache, arm soreness,
SIDS-pt found by mom (evening following vax administration) unresponsive & blue-ER resusciation efforts unsuccessful
Patient presented to receive COVID vaccination. He was deaf and no translator was available. He had filled out the immunization consent form and the responses were used for screening. He was asked if this was his 1st dose. He had marked he has not received a dose of COVID-vaccine and acknowledged as I pointed to the question. Vaccine administered and patient monitored for 15 minutes. Upon leaving, the patient asked volunteer about need to schedule a second dose. it became understood that he has previously received a dose in March and lost his COVID card. Upon verifying the patient's profile, he previously received Moderna and was injected with Pfizer today. Patient advised no additional COVID vaccination dose required. Patient with no insurance and no medical provider to contact.
Woke up on 10/28 around 7am - left arm hurt and was very itchy- - felt itchy all over- red patch around injection site was raised and red and swollen- took 50mg benadryl-  marked arm with black marker- as day went on- every 4-6 hours- arm would start hurting and be real itchy again- and red area would continue to grow and continued to itch all over body from inside out- took 175 mg benadryl on 10/28 as well as prednisone 20mg-  continued to take benadryl until 10/31- arm redness subsided a little each day and was back to normal on 11/1. Checked in with  nurse on morning of 10/28 who advised me to see primary provider and take benadryl and use hydrocortisone cream
6/14/22 1:45-2:30pm Metallic taste in mouth 6/15/22 3:15am Chills, aches 4:00am Chills, aches, sweating, fever (102.4°). Took Tylenol.  4:45am -3:15pm Chills, aches, sweating, fever (102.4°), Vomiting, Nausea, Unable to keep food or water down.
Patient said she experienced syncope 10 hours after vaccination. She said that she experienced headaches, low grade fever, fatigue, and elevated liver enzyme levels (ALT/AST). She said she still feels slightly fatigued these days.
December 18, 19, 20 fever 37.7C little vomit. December 21, 22, 23 rush (still today rush) started on head chest back and slowly took over all body. All these days poor appetite, refuses to eat mostly milk only.  Diarrhea.  Sleeping bad in night wakes up crying. Day time more sleepy, fussy.
Patient reported soreness, redness that's spreading, swollen at the injection sites and pumps on the arm. Pharmacist advised patient to use BENADRYL and seek medical help if condition is not improved.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 ANGINA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 DM 2 W POLYNEUROPATHY J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 CKD STAGE 4 (GFR 15-29) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 ANGINA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 ANGINA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 APHASIA, LATE EFFECT OF HEMORRHAGIC STROKE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 ANGINA, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 HX OF RECTAL BLEEDING J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 APHASIA, LATE EFFECT OF HEMORRHAGIC STROKE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/8/2022 EDEMA
redness/swelling/pain at the injection site after the injection. The patients husband said she was having trouble lifting her arm and was only able to lift her arm using her other arm. The patients husband said he has given her tylenol.
On 5/22/01, the pt received her 1st 0.5ml left leg injection of Engerix-B. Post vax, on 5/22/01, the reporter stated that the pt developed a local reaction characterized by a round lump on the left leg that was extremely itchy. The lump was 1.5" to 2" in diameter. The reaction lasted for "about" 3 weeks. As of 10/30/01, the local reaction had resolved.
Patient received Pfizer-BioNTech as the 3rd dose in a series due to being immunocompromised.  It was after the dose was administered that it was identified that the patient had received MODERNA for dose 1 and dose 2.
Narrative:  Unclear exactly what happened, pt reported the allergy and symptoms about 2 weeks after COVID vaccine was administered. Per chart review, PCP also notes that pt was seen at ED and was found to have CHF so may be unrelated
Almost going to pass out; she sees the room as color yellow and red; sweat breakouts; This is a spontaneous report from a Pfizer-sponsored program reported from a contactable consumer (patient's mother). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation. Patient age at vaccination was 40 years. The patient's medical history and patient's concomitant medications were not reported. The reporter stated the patient had COVID-19 vaccine 3 weeks ago and she will have the 2nd dose of vaccine 'tomorrow'. The reporter was kind of nervous about her getting the 2nd dose as the patient is experiencing a sweat breakouts and almost going to pass out, she sees the room as color yellow and red. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Aches, headache, fatigue, vomitting.  Started roughly 24 hours after shot. Had muscle spasms and severe vomitting.
HYPOTENSION 5/4/2023 DM 2 W RENAL MANIFESTATION HYPOTENSION 5/4/2023 CKD STAGE 3A (GFR 45-59) HYPOTENSION 5/4/2023 HYPERCHOLESTEROLEMIA HYPOTENSION 5/4/2023 SYNCOPE AND COLLAPSE
My COVID-19 symptoms started on 12/12/2022 at around 07:00PM. I had sore throat, cough, low grade fever,  runny nose, congestions, fatigue, and headaches. I tested positive with a home test on 12/15/2022.  I called the Nurse line o the same day. They prescribed me with Paxlovid for 5 days. As of today 12/21/2022 I am feeling  better but I still have congestions.
Patient had been given a Prevnar13 vaccination in April, 2019.  Pharmacist administering vaccination did not check the state registry prior to administering vaccination just went off of patient reporting vaccine naive.  Employee called the patient to explain the situation and set up an appointment for patient to receive pneumovax23 greater than 1 year from Prevnar13 dose given in December, 2019.
I noticed hives over right groin arae 2 by 7 cm red papules. I had no itching.  They resolves 11/21/2009 with no treatment.
Patient received Pfizer COVID vaccine on 2/15/21 (lot # EN6201), 3/11/21 (lot # EN6208), and 9/4/21 (lot # 30130BA). On 2/28/22, patient admitted to our inpatient med/surg unit with acute respiratory failure with hypoxia due to COVID pneumonia (tested positive upon admission), possible superimposed bacterial pneumonia, and acute metabolic encephalopathy. On 3/1/22, patient was intubated and transferred to CCU. As of today (3/3/22), patient is still admitted in CCU.