chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE WARMTH (area is a little warm to touch), INJECTION SITE REACTION (Injection site reaction), SKIN REACTION (Delayed skin reaction), VACCINATION SITE INDURATION (induration) and VACCINATION SITE PRURITUS (itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K2A and 039K0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Atopy. Concurrent medical conditions included Drug allergy (Allergic to mangoes). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN D NOS for an unknown indication.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 27-Dec-2020, the patient experienced INJECTION SITE REACTION (Injection site reaction), VACCINATION SITE INDURATION (induration) and VACCINATION SITE ERYTHEMA (area of redness 4-5 cm). On 02-Jan-2021, the patient experienced SKIN REACTION (Delayed skin reaction). On 03-Jan-2021, the patient experienced INJECTION SITE WARMTH (area is a little warm to touch) and VACCINATION SITE PRURITUS (itchy). On 28-Dec-2020, INJECTION SITE REACTION (Injection site reaction) had resolved. On 04-Jan-2021, VACCINATION SITE INDURATION (induration) had resolved. On 11-Jan-2021, SKIN REACTION (Delayed skin reaction) had resolved. At the time of the report, INJECTION SITE WARMTH (area is a little warm to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (area of redness 4-5 cm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2021: additional SD received On 28-Apr-2021: Follow up received on 28APR2021, added information on reporter details (address, email), patient demographics (height, weight and race), patient medical history and also report additional events for 1st dose ( Injection site reaction, delayed skin reaction) and reports 2nd dose details and events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information received from published information indicated that a 39 yr old health care worker developed varicella with 10 lesions 8-14 days. Secondary transmission was noted. Analysis of material from this secondary case indicated that it was also vaccine strain, which occurred despite a previous history of wild type varicella. There was no evidence of immunosuppression by clinical history or immunologic testing, and the pt was not taking immunosuppressive medications. The published information also discussed 3 other cases (WAES0403USA01096, WAES0403USA01097, and WAES0410USA01876).
sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: sore arm).The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that so far, he/she had no complications other than a sore arm. The follow up would not possible as no contact details were available.
Pt reports same day face distorted, swelling, pain, stiffness, shoulders,neck,ear,back, vertebrae,hip joints, legs,arms. Cannot walk without pain, cannot lift without pain. Pt had x-rays and 2 MRI's. Treated with Celebrex, did not eliminate pain. Predizone and Indocin helped but did not eliminate painful condition, physical therapy no help.
Fillers were nodular and hard; This is a spontaneous report from a contactable other hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injec-tion, Batch/Lot number: not reported)), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. botulinum toxin type a (BOTOX), route of administration, start and stop date, batch/lot number and dose were not reported for an un-specified indication. The patient medical history was not reported. The concomitant medication(s) include voluma in cheek on 25Jun2020 of last year no fillers since that date, volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week. The patient experienced fillers were nodular and hard. botox has voluma in cheek (25Jun2020 of last year no fillers since that date) last week was supposed to have another procedure that is when nodukar was seen and said she had vaccine 2 weeks told her Pfizer they did not do Botox no info on that last week Mar2021no labs no meds no previous surgerys Voluma lot VB20B00020 Expiration Jun2021 did volbella in different area V15LA80728 EXP Sep2020 treatment was in June 2020 did not use fillers when AE happened patient saw last week coming in for botox she had filler in the check when she came in it was very nodular and hard had covid vaccine 2weeks prior.The action taken in response to the event(s) for botulinum toxin type a was un-known. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported back to pharmacy on 12/04/17 showing pronounced redness on arm around injection site.
a slightly tight chest and it hurts a little bit around my chest area; a slightly tight chest and it hurts a little bit around my chest area; sore arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first bnt162b2 (Solution injection, Batch/Lot Number: EW0172), via an unspecified route of administration on 20Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Aug2021, patient experienced after the first shot, sore arm but that was fine But today patient like a slightly tight chest and it hurts a little bit around patient's chest area. Patient questioned if this should be a concerned or was normal. The outcome of the events was unknown.
Covid; Initial information received on 04-Feb-2021 regarding an unsolicited valid serious case from a non-health care professional via media (under reference SAC20210210000330 and comment id 701063607238447).  This case involves patient of unknown demography who experienced covid (Coronavirus disease) (covid-19), after receiving INFLUENZA VACCINE.  The patient's did not get the flu shot for the past 30 years.  Past medical treatment(s), vaccination(s) , concomitant medication(s) and family history were not provided.   On an unknown date (in November, year unspecified), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (in December, year unspecified), the patient went to the hospital in December with the COVID for 13days, approximately one month following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for the event.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number for this case to be requested.; Sender's Comments: This case concerns a patient who presented with covid-19, after vaccination with INFLUENZA VACCINE. The time to onset is unclear. However, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Patient states "tingling" sensation on right upper lip. Swelling, redness, or pain noticed at site. Seen by EMT. Revealed 0 swelling, redness or pain at site .
Pt woke up the day after receiving the vaccine with left arm pain, redness at site, red mark in shape of band-aid around the injection site.
This case was reported by a lawyer and described the occurrence of loss of concentration in a 42 year old female pt who received Lyme disease vaccine recombinant (Lymerix) injection for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date, the pt received Lymerix.  At an unk time after receiving Lymerix, the pt experienced tingling, burning, joint pain and muscle twitching, loss of concentration, paresthesias, headaches, and other neurological symptoms. Time to onset, treatment, and outcome were not reported.
Hives L arm below injection site about 48 hours after administration, slight R sided swelling of tongue. Took OTC Benadryl, tongue resolved, hives resolving more 96 hours later.
pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; pain, redness, itching, and hotness in the vaccination site.; spread and gotten worse.; still painful, red, and swollen.; still painful, red, and swollen.; still painful, red, and swollen.; A spontaneous report  was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen,  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the events,pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen.  Treatment details included Antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, pain, redness, itching, and hotness in the vaccination site, spread and gotten worse, still painful, red, and swollen was unknown.
Swollen neck lymph nodes,  chills, fever, nausea,  headache,  sore arm, muscle aches
Approximately 10 days post vax, pt felt slightly achy all over. Pt developed a fine rash on the abdomen, chest and axillary area. Pt also experienced fever and arthralgia.
Tolerated  the injection in office ok but later at night mom noted redness at Quadracel vaccine site on rt shoulder/upper arm area.  Subsequently had spotty rash next day on rt chest.   No itch or discomfort.  No fever.  Was able to use arm ok and acting usual self.   Rash lasted 1-2 days.   Photo sent on day 2 showed faint pink rash  in chest/axilla area  (could not distinguish much else).
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 14 years. It was also confirmed that on 28-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1709USA005743: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1708USA001768: US-009507513-1709USA005739.
no adverse event; Improperly stored administered vaccines; This spontaneous report was received from a registered nurse and from vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions and concomitant medications were not reported.   On 14-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T041687 expiration date 10-DEC-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). The suspect vaccine was stored in a temperature from -10 degree Celsius (C) to 8 C for 5 hours and 10 minutes. There was previous temperature excursion - the vaccine was stored in a temperature from -10 C to 8 C for 8 hours and 41 minutes and for 3 hours and 35 minutes. No additional adverse events were reported (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2110USA005066: US-009507513-2109USA006582: US-009507513-2109USA006583: US-009507513-2109USA006584: US-009507513-2109USA006585: US-009507513-2109USA006586: US-009507513-2109USA006587: US-009507513-2109USA006588: US-009507513-2109USA006589: US-009507513-2109USA006590: US-009507513-2109USA006591: US-009507513-2109USA006592: US-009507513-2109USA006593: US-009507513-2109USA006595: US-009507513-2109USA006596: US-009507513-2109USA006597: US-009507513-2109USA006537:
Started out with nausea and sore arm site felt hot. Then I started running a fever of 100.4  slept most of  day then I had a headache  took excedrin migraine went back to bed. When I got up fever was  99.4 had diarrhea and fever lasted rest of the night . Sunday morning got up felt a little better.
again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time; again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Jan2022 (Lot number: FJ6369) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetic", start date: 1994 (ongoing), notes: Verbatim: Diabetic; "immune deficient" (unspecified if ongoing), notes: Caller states he is diabetic, immune deficient. There were no concomitant medications. Vaccination history included: Bnt162b2 (First shot was on 17Mar2021. He didn't experience the swelling so much. Lot number: ER2613.), administration date: 17Mar2021, for COVID-19 Immunization, reaction(s): "First shot was on 17Mar2021. He didn't experience the swelling so much"; Bnt162b2 (He got the second one on 07Apr2021. Lot number looks like EB8729), administration date: 07Apr2021, for COVID-19 Immunization, reaction(s): "experienced painful swollen glands in his neck and armpits that resolved after 3-4 months", "swollen glands in arm and neck".  The following information was reported: LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", AXILLARY PAIN (non-serious), outcome "unknown" and all described as "again experiencing swelling in his armpits, however "not as bad" and glands are not currently painful this time".
Fast heartbeat, rash,  swollen throat, dizziness, headache, chills, fever, nauseous
Pharmacist reports an inadvertent concomitant administration of VARIVAX and PROQUAD to a 1 year old patient on 25AUG2022. No additional AE reported. No PQC reported.; Pharmacist reports an inadvertent concomitant administration of VARIVAX and PROQUAD to a 1 year old patient on 25AUG2022. No additional AE reported. No PQC reported.; This spontaneous report was received from a pharmacist concerning a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.  On 25-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (strength and route of administration were not reported), lot number W016357, expiration date 16-NOV-2023, administered for prophylaxis, and inadvertently concomitantly the patient received a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (strength and route of administration were not reported) lot number U028165, expiration date 09-SEP-2023, administered for prophylaxis (accidental overdose). No additional adverse events were reported (no adverse event).
Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; Fever fatigue tired , body aches , shortening of breath, even after 5 days, getting worse daily; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Apr2021 at 18:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient previously had sulpha and experienced sulfonamide allergy (reported as sulpha). Concomitant medications taken within two weeks prior to vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 06:00, the patient experienced fever fatigue tired, body aches, shortening of breath, even after five days, it was getting worse daily. No therapeutic measures were taken as a result of the events. The clinical outcome of the events fever fatigue tired, body aches, shortening of breath, even after five days, it was getting worse daily was not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected
Day 0 of vaccine  Day 1 - fussiness/single episode of vomiting Day 2-4 - loose stool, lasted 2-3 days Day 3 -5- urticaria of extremities, brief, self resolving
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient is a 62 years old female with past medical history of Hypertension, Neuropathy, Hypothyroidism, CAD, DVT, Alcohol abuse, Nicotine dependence, Cachexia. Per follow up note on 4.9.21 patient had uncontrolled blood pressure, and dramatically lost weight over last 2 years. Patient also smoked 1/2 to 1 pack per day. Per notes from last few months patient had problem with leg swelling and pain which was not resolving. Patient was started on Chlorthalidone and for DVT txt patient was on Apixaban. Patient had history of fracture to left tibial plateau in sept 2020. Other than this there were no note found on chart for ER visit or hospitalization recently. Patient passed away on 5.8.2021.
This spontaneous report as received from a pharmacist refers to a 24 year old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date in February 2010, the patient was vaccinated with the first dose of GARDASIL for prophylaxis. On an unknown date in November 2011, the patient was vaccinated with GARDASIL for prophylaxis. The patient experienced no adverse event.
I have a confirmed case of mild shingles rash on chest.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ECO0170), via an unspecified route of administration, administered in Arm Left on 29Apr2021 10:45 (at the age of 43-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to Sulfa- mild rash. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: CP7533), administered in Arm Left on 08Apr2021 10:30 (at the age of 43-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine in four weeks and did not receive any other medications in two weeks. The patient reported she had a confirmed case of mild shingles rash on chest on 03May2021 13:00. Patient did not have COVID prior vaccination and COVID was not tested post vaccination. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for adverse event that included Antiviral medicine and ointment. The outcome of event was not recovered.  No follow up attempts are possible. No further information is expected.
Had the 2nd Pfizer Covid shot on 3/14/2021 around 5:30pm. Typical arm soreness and all body achiness from 1am 3/14/21 til 3/16/21 morning. On 3/16/21 evening, right calf muscle started twitching a lot and feeling like it would cramp although it wasn?t painful. This happened throughout the day and night; slept with right leg raised on a pillow on 3/17/21 evening. Today, 3/18/21, right calf and leg feel better. Not sure if the muscle twitching and feeling like it would cramp (not painful, just uncomfortable; no swelling, no warmth on leg, no hard veins or arteries) was related to the shot.
A report was received from a health care professional on 11/08/02, concerning an 81 year old female vaccinee who experienced blurred vision and double vision immediately after receiving Fluvirin on 10/30/02. At the time of reporting the vaccinee had not yet recovered. There was insufficient information to determine the reporter's causality assessment.