chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash - red, splotchy over whole body - urticaria vaccine site was fine - no swelling or tenderness.
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 31 year old female pt stated that administration of vaccination was very painful and burned a lot. The pt experienced immediate swelling and redness. Approx. 2 hours, post vax, she experienced tachycardia, difficulty breathing, nausea and vomiting, headache and lightheadedness. Within 15 minutes of onset, she experienced hives all over her arm. The nurse responsible for vaccination went to the pt's home and told the pt to take Benadryl 2 tablets every 4-6 hours. At the time of this report, the pt was experiencing "flu-like symptoms" and had a "very bad headache". Upon interview, it was discovered that this pt has severe allergic response to "all food coloring, additives and preservatives" and is allergic to "all 'chillin's". She describes her previous reactions as severe hives, skin sloughing, nausea and vomiting and headache. Writer expressed the need for this pt to be evaluated by her physician ASAP. Follow up #1 06/05/02: During internal auditing of all files, it was deemed necessary to amend the report by updating the Adverse Event coding (Added Dyspnea, Tachycardia, Medication Error, Vomiting  and Nausea). Also re-ranked all coded terms.
PATIENT REPORTED NUMBNESS/TINGLING SENSATION ON LEFT SIDE OF FACE ABOUT 2 HOURS AFTER VACCINATION.  PATIENT FEELS EFFECTS GETTING BETTER 4 HOURS AFTER VACCINATION.
Painful cramping, nausea and some diarrhea after GARDASIL 9 vaccine. 14 year old boy. Started the next day and carried over another day.
Severe right arm and leg pain and weakness, progressed to inability to move arms and legs while in emergency room.
Did not feel very well for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel very well for a couple of days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 0062G21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (Did not feel very well for a couple of days). At the time of the report, MALAISE (Did not feel very well for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: high (High) elevated Heart rate for two days..         No concomitant medication were reported. No treatment information was provided by the reporter.   This case was linked to MOD-2021-311007, MOD-2021-311053 (Patient Link).
receiving Pfizer COVID 19 vaccine booster shot; developed injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Batch/Lot number: unknown), for COVID-19 Immunization; Bnt162b2 (2nd dose, Batch/Lot number: unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "receiving Pfizer COVID 19 vaccine booster shot"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "developed injection site soreness". Additional information: patient developed injection site soreness that started 12 hrs after injection and lasting 24 hrs. No other symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On multiple unspecified dates, the patients' were vaccinated with improperly stored doses of VARIVAX (Merck) lot # L013063 expiration date 14-APR-2017 (dose and route of administration were not reported). The temperature excursion was 6.8 degrees F but time frame was undetermined at the time of the report. No previous excursions were reported. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Patient describes generalized fatigue paired significant discomfort on the left side of his chest, below concentrated just below the breast. Denies any shortness of breath. Pain is described as a dull ache and began the day after the vaccine was administered and has yet to abate. Pain level does not fluctuate despite activity or lack of activity.
Soreness at site of injection, erythema. Temperature 102. Now 98.5. Felt warm and lethargic. Staring day after injection. Erythema 7x6 cm left deltiod arm. BP 104/60. Acetomenophin advised.
severe dehydration; Initial information was received on 20-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case is linked to cases 2021SA350364 and 2021SA355220 (same reporter).  This case involves a patient (unknown demographics) who had severe dehydration (dehydration) after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included influenza vaccine (two times) for prophylactic vaccination and the patient had flu (influenza) as a reaction to the vaccine.  The patient's other past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a third dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious severe dehydration (dehydration) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "every time I have gotten the flu shot I ended up in the hospital that week from severe dehydration. Not everyone's bodies are the same! My brother gets it and does well! Swears by it keeping him from getting flu bad! So people do end up in the hospital from the flu vaccine. No one should be pressured to make medical decisions for themselves! The first two times I had the flu vaccine I thought it was coincidence that I ended up with the flu that bad same week. After the third time I ended up in the hospital after I said to myself never again! I have not had the flu bad like that since. Same for my kids. They got sick bad every year after getting it. Have gone a couple of years now without getting it! No 105 fevers, No throwing up, no diarrhea bad at the same time! I have triplets so when they all get bad sick like that and I do too it is exhausting! Never again! They had to go to the emergency room also because their fevers were so high and kept going up after flu shot! One of my triplets has peanut tree nut allergies so not taking chances anymore."  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Pt c/o nausea, chills, and rigors. Water given at 1435. At 1439 pt c/o shaking. BP taken 180/74. BP retaken 190/86 at 1440.  SpO2 98%, Temp 36.8C 1448: BP 187/83 1454 BP 175/77, HR 86, Temp 98.8
Both arms were very sore, the left had severe muscle spasm couldn't raise are for three days after third day, symptoms subsided.
Swelling, redness, heat at site 4 x 4.5 size, rash, nausea, fever, muscle ache.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions or allergies and concomitant medications was not reported. On 20-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 -10PK-0.5ml SD-PFS LLok w Tip, which had the lot # K010465, with expiration date 23-MAR-2016 (dosage number and route of administration were not reported). No adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced temperature excursions of 16 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius degree). The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
3am - woke up crying & screaming - had high fever (mom didn't have thermometer) red cheeks, swelling at sights of injections - mom gave ibuprofen & child went back to sleep; woke up again vomiting would jerk - so much that he hit himself in the head but he seemed not to notice - he just stared. He went back to sleep & in the morning he was moving slowly, drooling a lot, bump his head into the wall or curl upon his side on the floor, still staring a lot, wasn't talking. Mom took him to Dr at 3:45pm on 11/30/01. Dr felt child had had some sort of seizure. possibly due to high fever or reaction to shots. Dr told mom that when child comes for DTaP booster - he should not get Pertussis vaccine. Each day child has improved. As of 12/3/01 child is behaving normally except for decreased appetite.
I woke up the day after with a painful back and strong nausea. I had diarrhea. Had a bit of fever (38 degrees) and felt very weak.
Tenderness at injection site; Little swelling at injection site; Rash site; Fatigue; Lymph nodes in front of right ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: EW0183) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN. Past drug history included: Codeine, reaction(s): "Allergies: Codeine", notes: codeine. Vaccination history included: Bnt162b2 (Dose 1, Product=COVID 19, Brand=Pfizer, Lot number=ER8730, Administration time=04:00 PM, Vaccine location=Left arm), administration date: 27Mar2021, when the patient was 54 years old, for COVID-19 immunization, reaction(s): "tenderness and a little swelling at injection site", "Tenderness", "Fatigue". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Tenderness at injection site"; VACCINATION SITE SWELLING (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Little swelling at injection site"; VACCINATION SITE RASH (non-serious) with onset 26Apr2021, outcome "recovered" (May2021), described as "Rash site"; FATIGUE (non-serious) with onset 26Apr2021, outcome "recovered" (29Apr2021), described as "Fatigue"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Lymph nodes in front of right ear". Therapeutic measures were not taken as a result of vaccination site pain, vaccination site swelling, vaccination site rash, fatigue, lymphadenopathy. Additional information: The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.   No follow-up attempts are possible. No further information is expected.
Received expired dose of the Moderna vaccine (6 months stored in the refrigerator); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine (6 months stored in the refrigerator)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The treatment information was unknown. Dose administered after 30-day use by date or after manufacturer date of expiry.
Tired; Arm hurt; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-CA) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 2), Pfizer vaccine (Dose 1) and Pfizer vaccine (Dose 3). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2022, the patient experienced FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt). At the time of the report, FATIGUE (Tired) and VACCINATION SITE PAIN (Arm hurt) outcome was unknown.            No concomitant medication details were reported. No treatment medication details were reported.   This case was linked to MOD-2022-654638 (Patient Link).
Patient developed pancytopenia, fevers, elevated liver enzymes, elevated ferritin suggestive and elevated solubleIL2R  of HLH (hemphagocytic lymphohistiocytosis.)
Sore throat night of vaccine.  Next day, sore throat, cough, weakness, yellow sputum.  Day after that, same symptons, shortness of breath, wheezing. Day after that, same symptoms plus fever.
No temp, no pain, no changes in behavior. Redness and swelling Left arm 2cm larger than Right arm. No nodes swollen or tender.
getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp.  A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events.  Follow-up attempts are completed. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 62-year-old female patient who received SHINGRIX (batch number A4X57, expiry date 31st July 2020) for prophylaxis. Concomitant products included BOOSTRIX, Calcium Unknown and Vitamin D3. On 22nd May 2018, the patient received the 1st dose of SHINGRIX .5 ml. In May 2018, less than a month after receiving SHINGRIX, the patient experienced swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased were recovered/resolved. The reporter considered the swelling arm, injection site erythema, feels awful, pain in arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: Concomitant products included Echinacea. The nurse reported that the patient received the SHINGRIX vaccine in the left deltoid and experienced severe swelling on her left arm that lasted nine days after injection. The patient had pain for 24 hours after injection and where she was unable to move. Two days after immunization the patient felt terrible with redness at the injection site and the patient had an area of redness which was approximately 15 cm x 10 cm. At the time of reporting the redness had resolved.
Two hours after flu shot, said was hard to breathe and was holding his chest.  Throat clearing.  Hives all over body (I reviewed pictures and agree these were hives).  Benadryl given.  Called EMS.  To ER.  Symptoms improving when arrived, but not gone.  Given Dexamethasone and monitored for 2 hours.  Epi not given.   The following day, he had a large erythematous macule partially surrounding the area where the shot had ben given, with small raised pale bumps scattered throughout that macular area.
This case was reported by a pharmacist (subject) via sales representative and described the occurrence of injection site blisters in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In October 2013 the subject received unspecified dose of FLULAVAL (unknown, unknown arm). In October 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering") and indentation at injection site (described as "has 'crater' in arm"). At the time of reporting the outcome of the event of injection site blisters was unknown. The outcome of the indentation at injection site was unresolved. The pharmacist reported other cases with FLULAVAL. See cases A1052878A and A1052879A for details.
Swelling, heat, redness of entire upper arm, and also repored shortness of breath starting the night after receiving the vaccine.
Mother reports post vaccine pt was fussy, low grade fever, later fever of 104F with diffuse rash all over body of erythematous morbilliform spots.
Patient was given .5ml of Moderna vaccine instead of .25ml for 2nd covid booster.
p/vax pt exp extreme soreness in upper & lower lt shoulder;p/2wk pt showed the MD huge knot that was on arm;pt stated hurts to write & lift thing;exp neck pains;
This spontaneous report was received from a physician via company representative referring to an 18-year-old male patient. He did not have any pertinent medical history, concurrent conditions and he did not take any concomitant medications. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, vaccination site, lot number and expiration date were not reported) as prophylaxis. On an unknown date, 24 hrs after the vaccination, the patient broke out with hives. No lab diagnostics/studies were performed. The patient received an unspecified treatment and recovered from the event on an unknown date. The causality between the event and GARDASIL 9 was not reported.
3/27/04-Taken to ER with redness, tenderness, and warm to touch at left leg injection site. Slight redness first noticed 3/26/04 at home.
Patient stated she didn't feel any symptoms after the 1st vaccine. She started experiencing symptoms after the 2nd. She took vaccine on Friday 5/7/21 and woke up Saturday morning and felt like she had a minor flu, scratchy throat/soreness, with muscle soreness, body aches, hot flashes, sinus headaches, she was unsure if she has a fever, feels very fatigued, tired, sleeping more than usual, no chest pain, n/v. She took Thera-Flu and Ibuprofen 800mg for her period. Advised to continue with the Thera-Flu, ibuprofen or Tylenol to help with the current symptoms but if she felt she was getting worse then to go see a PCP or urgent care.
This spontaneous report was received from a healthcare worker refers to a female patient of unknown age. No medical history was reported. Patient received her first dose of GARDASIL on 04-JUN-2013, her second dose on 24-AUG-2012 and was in office today 21-JUN-2013 to receive her third dose of GARDASIL (lot #, expiry not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 14th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th April 2018, 1 days after receiving SHINGRIX, the patient experienced fever, injection site erythema and chills. On 17th April 2018, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site erythema was recovering/resolving. The reporter considered the fever, injection site erythema and chills to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid on 14th April 2018 at 11:27. The health care professional reported that patient received their first dose of SHINGRIX and the next day experienced fever and chills that lasted for 2 days then resolved. Additionally, he developed a red spot (size is about the size of a half dollar) about an inch below the injection site the day after he was administered SHINGRIX. It was getting better but has not yet resolved.