chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red nodule at injection site; Elevated Injection Site; Itching Injection Site/and it is itching; rash is persisiting; rash was itchy; rash below the injection site on the right arm; This spontaneous case was reported by a nurse and describes the occurrence of RASH PRURITIC (rash was itchy), VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching) and RASH (rash is persisiting) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ONDANSETRON for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (rash below the injection site on the right arm). On 08-Apr-2021, the patient experienced RASH PRURITIC (rash was itchy) and RASH (rash is persisiting). On 10-Apr-2021, the patient experienced VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site) and VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching). The patient was treated with TRIAMTERENE (topical) for Vaccination site rash, Itchy rash, Rash and Injection site nodule, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (rash was itchy), VACCINATION SITE NODULE (red nodule at injection site), VACCINATION SITE REACTION (Elevated Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site/and it is itching), RASH (rash is persisiting) and VACCINATION SITE RASH (rash below the injection site on the right arm) had not resolved. Not Provided      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.   This case was linked to MOD21-073525 (Linked Report).; Sender's Comments:  MOD21-073525:
Ear pain in the right ear began shortly after the vaccine, by the next day it was in both ears.  Constant pressure/pain.  Severe constant pain lessened after 3-4 weeks but pressure and pain occurred intermittently  still at 12+ weeks after vaccine.  As the pain and pressure reduced, tinnitus began to occur more regularly.  No history of ear pain/pressure or tinnitus prior to the vaccine.
PATIENT DEVELOPED RASH 15 MINUTES AFTER SEASONAL FLU VACCINE ADMINISTERED.
Bleeding and bruising problems at the slightest bump I will get small hematomas, petechiae and bruising repeatedly and easily. It hasn't stopped for an entire month.
Not sleeping well through the night like usual, Rash for 3 days from head to toe, swollen crusty eye, low grade fever 99 to 100.4.
24 hours Chills/body aches fever 102.5 Next 24 hours chills/body aches fever 101.5 Headache/ injection site itchiness for 3 days lethargic and shaky Total recovery time 36 hours
This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 17-year-old male patient started to receive TRUMENBA, (Lot number and expiration date were not reported), with route of administration and therapy date unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had low grade fever and malaise. The outcome of the events, low grade fever and malaise, was unknown. Information on the batch/lot number has been requested.
w/in 48 hrs devel severe h/a t102, achy joints lasted 4 days; like bad flu;
Patient states 24 hours after vaccine, she developed rash, hives, tongue and throat swelling.  She received medical help immediately and is fine now.
Feels like swollen lymph nodes:Right armpit Behind both ears Right side of neck; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 25Feb2021 at 11:30 AM (at the age of 51 years old) at first dose, single dose for COVID-19 immunisation. The patient has no relevant medical history and has no known allergies. The patient was not pregnant at the time of vaccination. The patient was taking unspecified medications in two weeks within vaccination. The patient reported that she felt like having swollen lymph nodes: right armpit, behind both ears, and at the right side of neck on 11Mar2021 at 09:00 PM. The patient has no COVID-19 prior to vaccination and was not COVID tested post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
feeling unwell; feeling like death; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a 70-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for an unknown indication.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced feeling unwell and impending doom. On an unknown date, the outcome of the feeling unwell and impending doom were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and impending doom to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. On unspecified date in 2019, the patient received the flu shot and was laying on the sofa feeling like death (feeling unwell) and Impending doom. The patient response that the patient would never have the vaccine and keep the vaccine away from the patient. On the day of reporting, the patient was of 70 and mention never had a flu shot, never would and never had flu shot. Though most of the patient's friend had the shot. All of them had filed adverse event.
This spontaneous report as received from a other health professional refers to a male child between 4-6 years of age with no reported medical history. On an unknown date, during the 12-15 month well check up visit, the patient was vaccinated with his first dose of M-M-R II (date, dose, and route and lot number unknown). On an unknown date the patient was vaccinated with his standard second dose of M-M-R II (date, dose and lot number unknown). No other suspect therapies were reported. Concomitant therapies included varicella virus vaccine live (manufacturer unspecified), DTAP and poliovirus vaccine inactivated (manufacturer unspecified). On 19-MAR-2013, reported as last week, the patient developed a hard, red, swollen leg in which the swelling was fairly severe after receiving MMRII vaccine. No treatment information was reported. The outcome of hard, red, swollen leg is unknown. The reporters relatedness of hard, red, swollen leg to M-M-R II is unknown. Additional information is not expected.
. Fever 102, muscles were so tight that she could barely move or bend arms or raise arms, screaming in abdominal pain (stabbing sensation). Fever seems to have passed, but she is still unable to lift arms and abdominal pain is still pretty severe. Mom has NEVER seen this type of reaction.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 14th March 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 20th March 2019, 6 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and pain in arm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and pain in arm were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, erythema of extremities and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received the injection on Thursday. On 20th March 2019, in the morning, when patient woke up, her arm was hurting, swollen and red from the injection site down to the elbow.
Complete paralysis of left side of face, severe left side head and ear pain, loss of taste and control of mouth, unable to close eye.  First symptom was loss of taste and inability to blink with left eye on the evening of 7/30/2021 and within hours overnight I had full paralysis and drooping on the left side of my face.
Information has been received from a physician concerning a patient who was vaccinated with GARDASIL. Subsequently the patient experienced complex regional pain syndrome number 1, that is, regional pain after vaccination. Additional information has been requested.
73 yo female, had reaction 1 hour after Pfizer Covid-19 vaccine 1/21/21- facial swelling, redness and respiratory symptoms- seen at ER, no epi given. Discussed with allergist, determined that receiving Janssen as an option (with risk involved), advised 1 hour observation in clinic. Pt received Janssen vaccine today. After 30 mins, pt complained of SOB, dry cough and sensation of losing her voice. Pt transported to ED with RN.
ADVERSE EVENT: NAUSEA, WEAKNESS, SHIVERING, SWELLING, FOGGY.
Acute/severe Vertigo. Started Thursday am at 7:00. World spinning. Nauseous. Dry heaves.  Called and went to doctor. Also physical therapist.
High fever of 105, delusions, hallucinations, weakness, swelling of face and neck and at immunization area, rash at immunization area, vomiting, diarrhea, pain and stiffness in the joints.
Developed symptoms the evening after vaccine administered. Sx included: nausea, vomiting, diarrhea, weakness, body aches, headache,  decreased appetite. Symptoms significantly improved after 3-4 days
shingles; arm was sensitive and warm; arm warm; rash on abdomen; rash on left arm , like a red oval around the injection site; rash on left arm , like a red oval around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (shingles), PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen) and VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 020L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site). On 30-Apr-2021, the patient experienced HERPES ZOSTER (shingles). The patient was treated with GABAPENTIN at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (shingles) had not resolved and PAIN IN EXTREMITY (arm was sensitive and warm), FEELING HOT (arm warm), RASH (rash on abdomen), VACCINATION SITE RASH (rash on left arm , like a red oval around the injection site) and VACCINATION SITE ERYTHEMA (rash on left arm , like a red oval around the injection site) outcome was unknown.            Treatment medication also includes antiviral for treatment. No Concomitant medication were reported.
Swelling, tenderness and erythema at site of previous dermal filler injections under eyes/upper cheeks (tear troughs) noted 24 hours after receiving 2nd dosage of vaccine. Swelling gradually worsened to involve bilateral tear trough regions - with maximal edema/erythema noted at approximately 36 hours post-vaccine.  Symptoms resolved gradually and were reported as minimal at 72 hours post vaccination. Patient had received dermal filler injection with Juvederm Volbella 0.55 ml approx 3 months prior to receiving the vaccination.
feel sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feel sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) at an unspecified dose. On an unknown date, the patient experienced MALAISE (feel sick). At the time of the report, MALAISE (feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
3-4 hrs p/vax, pt exp a decrease in hearing;1st MD found bil loss low/high pitches; 2nd MD felt deafness was r/t serous otitis & a myringotomy was planned; MD felt condition was OMIC
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 13-FEB-2023, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
1st night: Painful arm, swollen and tight, chills, fever, very tired. 2nd day: 103 fever, exhausted, can't get warm, arm very pain, swollen, red and tight, large lump. Headache. Dizziness. Drank lots of water and pedialyte, 3rd day:  Still feel dehydrated, arm is still very sore and swollen. 101 fever. Chills are finally subsided.
This case was reported by a healthcare professional and described the occurrence of a subject of unspecified age and gender getting sick following vaccination with FLULAVAL (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of FLULAVAL (unknown).  At an unspecified time after vaccination with FLULAVAL, the subject got sick.  At the time of reporting the outcome of the event was unspecified.  It was reported that 20 flu shots were given and three subjects got sick.  Follow-up information received on 13 October 2008 indicated that the event was not associated with FLULAVAL treatment, therefore, no additional information is expected.
left arm  was swelling from shoulder to elbow and got hot and red to touch/diagnosed as cellulitis; fever and chills; fever and chills; This is a spontaneous report from a contactable consumer (who is also the patient). A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ep7533), via an unspecified route of administration in the left arm, on 27Apr2021 17:30, as 2nd dose, single, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included psoriatic arthritis, strep cellulitis, known allergies to nightshade vegetables and dissolvable sutures. The patient was not pregnant at the time of vaccination. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination and the patient was not tested for COVID-19 since the vaccination. Concomitant medications included ixekizumab (TALTZ); valproate semisodium (DEPAKOTE); diphenhydramine hydrochloride (BENADRYL); and unspecified birth control; all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received at age 33 years, on 30Mar2021 18:30, administered in the left arm, for COVID-19 immunisation. The patient did not receive any other vaccine within 4 weeks prior to BNT162B2. On 27Apr2021, immediately after the first dose, the patient experienced swelling and redness at injection site. On 28Apr2021, the following day, the patient had fever and chills. These resolved on 18Apr2021 15:00. On 30Apr2021 15:00, the patient's left arm was swelling from shoulder to elbow and got hot and red to touch. These symptoms continued the following day and required doctor's clinic visit. This was diagnosed as cellulitis. On 01May2021, the patient started a 10-day antibiotic treatment for cellulitis. The patient recovered from swelling and redness at injection site, fever and chills on 18Apr2021 15:00.  The outcome of cellulitis was not resolved.
Tingling to the tongue, started 10 min after injection.  Pt was given 10 ml of Bendryl after 30  min of additional observation pt felt better and was able to leave the site.
DID NOT COMPLETE DOSES PRIOR TO TRAVEL TO AN ENDEMIC AREA; This spontaneous case (PVX2019-1176) was received from a consumer on 10-May-2019. It describes a female consumer who "did not complete doses prior to travel to an endemic area". The consumer was receiving Vivotif for a trip (endemic area).  Case report: The consumer took the first dose of Vivotif on 06-May-2019. She had a planned trip on 10-May-2019 (tonight). She already had taken two doses.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "did not complete doses prior to travel to an endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not complete doses prior to travel to an endemic area" was considered as not applicable.
24 hours after shot pt had swelling, tenderness and erythema of 1/2 left leg. Pt was treated in ER and MD's office with Benadryl and Zrtec
She said ever since receiving the COVID-19 Vaccine, she has been doing nothing but sweating; She said she will be sweating, and then she gets cold, and then she gets hot; This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL9261 on Arm, Left Upper at 10:35 on 22Jan2021 at single dose for covid-19 immunization.Medical history included : Type 2 diabetes mellitus (she has been a Type 2 Diabetic for over 10 years ).She said ever since receiving the COVID-19 Vaccine,on 22Jan2021, she has been doing nothing but sweating.She said she will be sweating, and then she gets cold, and then she gets hot .She said she feels like she is overheating. She said she is calling Pfizer to see what she should do. She said she hasn't called her doctor yet, and she is due to take the second COVID-19 Vaccine dose on 09Feb2021.Her sweating, and feeling cold then hot, started on Friday night, 22Jan2021. She said her face was even sweating when she was at work, clarifying she doesn't sweat like that. She said she was even sweating when she was sleeping. She said she will throw back the covers because she feels like she was overheating, and then 5-10 minutes later the heat dissipates, and she has to cover herself back up. This morning she had an episode of sweating, and thought her blood sugar was too high. She said she had just got out of the shower, and she was sweating. She said the ceiling fan was on. She said she was not feverish, but felt hot. She said she immediately checked her blood sugar, and her blood sugar was normal at 113.Her last blood work was in Dec2020. She said she she saw her doctor 3 weeks ago, and her blood work was OK.Outcome of the events was not recovered.
mom saw quarter size red, raised, tender to touch & warm area on lt thigh;inc to orange size area thigh by PM 0f 7/22/99 refusing to bear weight on leg;
Red raised rash on both thighs, has happened before at 6 wk vaccines & 4 month vaccines. Same shots given except flu given 2-10-12 her first time.
after the vaccination I had common symtoms, fever, chills and i was feeling sick for a couple of days, I started noticing tingling and numbness on my right arm and that never happened before, the tingling goes to my back as well at the same time, it is not all day, i get the feeling through the day, I also noticed I lost strengt on my right hand as well when this started, my hand gets numb, ive never had any neurological issues, this all started after the vaccine.
Headache; Face swollen; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: EP7534) via an unspecified route of administration in the left arm on 18Mar2021 at 08:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to tree nuts and coconut. The concomitant medications included prednisone (MANUFACTURER UNKNOWN),SINGULAIR, CLARINEX and Metoprolol (MANUFACTURER UNKNOWN) for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via an unspecified route of administration in the left arm on 25Feb2021 at 08:45 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient had tested positive for COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 at 09.45, the patient experienced headache within hour of vaccination and on 18Mar2021 face swollen in the morning after vaccine. Therapeutic measures were taken with ice and Tylenol for the reported events. The clinical outcome of the event headache and face swollen face were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
Rash, patches on body, chest, back, abdomen and legs.  Patient went to primary care physician who gave patient an injection of cortisone and Clarinex 5mg pills for the rash and itching.
Vaccine hurt more than other received vaccines in the past. Arm feels heavy and cannot lift/bear as much weight as previously able. Arm to wrist hurts (dull ache to sharp pains). Limited ability now with arm.
Pain in armpit beginning five days after injection, red rash and itching around injection site seven days after injection, rash and itching disappear after several hours, armpit pain remains
Red welt at injection site developed over 7-8 days. Recommended: M.D. visit. No tx. M.D. said no tx, no cellulitis, resolving.
Rash began as red spots on face 3/27/06 and then became vesicular. On 3/28/06 rash on arms and chest. Low grade temperature present. Using Benadryl PO for itching.