chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received bnt162b2 (BNT162B2), as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: PCN" (unspecified if ongoing); "known allergies: bee venom" (unspecified if ongoing); "CTCL" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: 33130BA), administration date: 31Mar2022, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FF2590), administration date: 13Oct2021, when the patient was 61-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EP6955), administration date: 25Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose"; bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EN6198), administration date: 04Mar2021, when the patient was 60-year-old, for Covid-19 immunization, reaction(s): "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "Experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose". The events "experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus. Additional information: The patient experienced bilateral, persistent tinnitus soon after receiving first dose, and worsens with each subsequent dose. Evaluated by ENT and audiologist. MRI ordered, no causes identified.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300321222 same patient/AE, different drug and dose;
funny taste in her mouth; tingling in her tongue; swelling; shortness breath; her chest was tight; she was not feeling 100%; difficulty swallowing; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Formulation: Solution for injection; Lot number and expiration date was not reported; NDC number and manufacturer: unspecified), dose 1 via an unspecified route of administration on 02Mar2021 (age at the time of vaccination 65 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had the Pfizer shot on 02Mar2021. She was wondering because right after, she did not have a severe reaction, but she did have a reaction. She had a funny taste in her mouth and her tongue was tingling on an unknown date in 2021 and that lasted for a few days, she felt okay but she had that feeling. She was sensitive to medicines, so she thought maybe it was just that but then Thursday morning (unspecified date in 2021) she had shortness of breath and difficulty swallowing and that lasted until Sunday and she thought she had a mild reaction and she was nervous about getting the second Pfizer shot. She wanted to know if she does not get the second shot, can she wait and get the Johnson and Johnson or if she doesn't get the second shot would she be protecting she just doesn't what to do with the first shot would she be okay if she did not get the second shot. She would really like to find out if she only got the first shot is that enough coverage for her. She had the funny taste sensation; it came and went since Tuesday morning. On Thursday morning, she woke up and didn't feel good, she had some swelling, shortness breath, her chest was tight. She went to the doctor, because she was not feeling 100%. On Sunday she felt better, she is much better than she was, but still has periods with "short of breath". She wanted to know how long will this last. Her doctor said she probably shouldn't take the 2nd shot. She is wondering if she can get the Johnson & Johnson vaccine instead of Pfizer's second dose. The outcome of the events was unknown.
A pharmacist reported the occurrence of erythema multiforme in a female whose age was less than 2 years who was vaccinated with Infanrix for prophylaxis. The subject's past medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received an injection of Infanrix; it was not known if she had received previous injections of Infanrix. On the same date, she received injections of IPOL, and MMR II. At an unspecified time post-immunization, she developed erythema multiforme. The reporting pharmacist was not sure if the erythema multiforme was caused by Infanrix or MMR II. As of 10/4/02, the event was "worse." Erythema multiforme is considered medically serious (OMIC).
On or about May 29th 2021 I noticed a small lump on my right testicle accompanied by a minor dull pain.. On June 14th I met with a Urologist at medical facility who performed the medical exam and tests and concluded that it was likely testicular cancer. On Friday June 18th I had surgery and began the treatment program.
Swollen above the skin; little redness around the injection site; This is a spontaneous report received from a contactable consumer or other non-health care professional (Patient's mother). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186), via an unknown route of administration, administered in Arm Left on 26Jul2021 (at the age of 12-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0282) via an unknown route of administration, administered in Arm left on 30Jun2021 (at the age of 12-years-old) as dose 1, single for COVID-19 immunisation. Patient received vaccination facility in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Caller stated that she is the mother of a 13 year old male who received his second dose of the Pfizer Covid 19 vaccine. He started to have a little redness around the injection site yesterday on 27Jul2021 and then today she states that it is red and swollen above the skin on 28Jul2021. She would like to know if this is considered normal or if she should seek. She wanted to see if that is normal and should she take him to hospital. The outcome of the events was reported as unknown.  Follow-up (19Aug2021): Follow-up attempts are completed. No further information is expected.
nausea after second shot; This spontaneous case was reported by a patient and describes the occurrence of NAUSEA (nausea after second shot) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea after second shot). At the time of the report, NAUSEA (nausea after second shot) outcome was unknown.            No concomitants and treatment medications were provided.
felt kind of weird; warm; temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt kind of weird), FEELING HOT (warm) and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 028A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced FEELING ABNORMAL (felt kind of weird) and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either). 09-Nov-2021, the patient experienced FEELING HOT (warm). At the time of the report, FEELING ABNORMAL (felt kind of weird) and FEELING HOT (warm) outcome was unknown and PYREXIA (temperature was 100.1° F, been having a fever of 100.1° or lower every day, not getting worse, but not getting better either) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, Body temperature: 100.1 (High) 100.1 degree F.         Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-390214 (Patient Link).
Patient had J&J administered two days ago and came in to get a booster. Patient came with her husband who had received the vaccine a year ago. Vaccine record card was reviewed but the year was missed. Pharmacist administered the vaccine. Patient had no adverse reaction.
Right after receiving the vaccine waiting my 15 minutes it felt tingling and burning sensation from my shoulder across my clavicle bone towards my heart. First 5 day (Tuesday-Sunday) symptoms: swollen, sore, red, & bruised arm at injection spot; body aches, joint  pain of knees, fatigue, no energy, loss of appetite, dry mouth, headache, chills, nausea.  I felt better on the 6th day (Sunday), the injection site looked like it was healing and going back to normal on my shoulder. Then on 7th day (Monday) my injection spot started to itch and break out in a huge hive and little hives around it.  It turned into a bright red circle around the injection spot.  It was hot to touch and very swollen. On 8th to current day (11th) my arm keeps getting worse with the swelling, hotness, itching, & redness, and spreading down my arm.
Given client expired Rotavirus; had client to wait 15 min after meds given, no problem noted. Inform Dr. and supervisor will call or send letter to revaccinate.
Vaccine was picked up from state department on 12/07/2021 to be stored in fridge and used by 01/07/2022. Patient received this dose seven days past the vaccine usage date. Patient reported no known symptoms.
Child had a DTaP (Daptacel, Sanofi-Pasteur) on 2/9/05.  Had mild URI symptoms.  Early the next morning, developed a fever and had a seizure.  Seen at hospital.  Felt to have had a febrile convulsion.  No apparent residual effects.
Friday, after the shots I felt real lethargic and my arm hurt just a bit. I went to go visit my mother who was in the hospital after an hour I started feeling light headed and felt sick to my stomach. I started sweating and my hands got real clammy. I sat down in the chair and passed out, just for a second. The nurses came in and took my pulse and said it was ok. but I was still real clammy. They got me a wet rag to put on my neck and a ice bag for my head. I felt better in about a half hour and went home. When I got home I just laid on the sofa with a blanket because I was getting the chills really bad. Still felt sick to my stomach, and at this point I couldn't even raise my arm. On Saturday I slept in and felt better, still couldn't raise my arm but decided to go to work. Half way through my shift my barback noticed that my knees and ankles were swelling up. I didn't feel anything at that point but later it got so bad that I could barely walk. My knees looked like grapefruits and my ankles tennis balls. When I got home I put up my feet. The next day the swelling went down, but after I went to work they swelled up again, but not as bad. Monday when I woke up the swelling went down somewhat but I wanted to play it safe so I went to my doctor. He didn't feel I was having an allergic reaction to the shots but that my body was just reacting to all that was going on. He thought that the shots might have reacted to one of my blood pressure medicines (AMLODIPINE or LISINOPRIL). Employee works two jobs. Has desk job and has bartending job night shift. Friday, Saturday, Sunday nights.
2 days after routine immunizations, awoke with 12cmx15cm redness at injection site right thigh. Diagnosed as cellulitis versus large local reaction. Given Keflex and Ibuprofen.
running fever for 5 days, no appetite, body aches. pharmacy said it wasn't normal.
After 10 minutes, mom noticed a reddish, bump rash on patient's left arm. Patient was behaving normal and no unusual symptoms other than the outbreak of rash (MMR shot).
My son received his ChickenPox Vaccine (booster) on Monday, March 17, 2008 and on Wed., March 19, 2008 what appeared to be a rash broke out on the small of his back.  The rash proceeded to get worse so we took him back in to see Dr. on Sat., March 22.  Dr. diagnosed patient with Shingles and perscribed:  Acyclovir 200mg (2 teaspoonsful 4 times a day) and Hydroxyzine 10 mg (1 teaspoonful every 8 hours as needed for itch).  Today is Wednesday, March 25 and the "rash" is still getting worse.  I was told by Dr. that it could take upto 3 weeks to see improvement.
Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4° fever Legs felt 'heavy'
Edema face and legs. BENADRYL 25mg, Prednisone 60mg, ZANTAC 150mg. Discharge Rx Prednisone 20 TID x 3 days, Omeprazole 20mg x 1 daily, Epinephrine auto-injector.
Both legs felt like they were vibrating?as if I was sitting on top of or leaning against a machine or car engine. The sensation occurred a few hours after the injection. It was not painful, it wasn?t spasmodic or like twitching. I initially thought my floor or chair I was sitting in was vibrating but as I moved to different areas of my home , I realized the sensation was in both of my legs.  It did not end until after I fell asleep later that night  (both times). It was gone when I woke up the next morning.
Information has been received from a health  professional concerning a 35 year old female with no known allergies who on 09-JAN-2008 was vaccinated with GARDASIL.  Concomitant therapy included unspecified vitamins.  On 09-JAN-2008 the patient received the wrong vaccine.  Instead of receiving the flu vaccine (manufacturer unknown), the patient received GARDASIL.  No adverse experience was reported.  The patient sought unspecified medical attention.  The outcome of the patient was not reported.  On 14-JAN-2008, additional information was received for the Pregnancy Registry for GARDASIL from the patient's brother-in-law.  He reported that the patient was pregnant when she received her first accidental dose of GARDASIL.  No adverse experience was reported. The patient sought unspecified medical attention.  Follow-up information has been received which reported that on an unknown date the patient delivered a normal infant with no congenital anomalies.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after shot). At the time of the report, PAIN IN EXTREMITY (Sore arm after shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment details was reported.
sore arm;chills, sweating, chest/heart pains nitro twice;ASA also given;
Patient presented to eye doctor with eye irritation - was diagnosed with corneal swelling due to recent SHINGRIX vaccination. She was aware of the possibility of this side effect and had seen it before.
Initial report received from a health care professional via MERCK on 31 August 2010. A neonate (sex not provided) received transplacental on 15 September 2010 FLUZONE, lot number not provided. The patient was born at 29 weeks gestation on 10 December 2009 with the mother's expected date of delivery (EDD) of 23 December 2009. The mother delivered preterm with prelabor rupture of membranes. The outcome was not reported. The mother's case was captured in case 2010-04804 and the other twin was captured in case 2010-04806. Documents held by sender: None.
10/10/16 Pt received vaccines-that night pt developed fever of 102. Mom took pt to ER. 10/11/16 mom noted 4 bumps on one leg and by end of the day rash on both legs at site of vaccines and noted red blotched on torso.
Patient called 6/20/19 - She reported general malaise on Saturday 6/15/19 and has felt fine the past few days. Thurday 6/20/19 she reports redness localized to injection site and it is itchy and warm to the touch. She drew a pen around the affected area and will report any changes. It is approximately 1.5 x 3 inch area.
Rash. Mom unsure of onset, but pt. had been seen in local ER 2/6/09 with no mention of rash she was treated for croup 2/6/09 with decodnon to EPI -- rash started 2/7/09 mom thinks.  I saw her 2/10/09 in office 0 Rx R-rash
Patient received Pfizer #1 on 1/6/21 and developed muscle cramps and tinnitus and was evaluated by ENT, TMJ specialist,allergist and her  PCP. Hearing test revealed mild hearing loss in high frequency.  1/27/21 received the second dose of the vaccine. The following day she developed flu-like symptoms, including fever, chills, headache and fatigue and worsening of Tinnitus.  Received Dupixent two weeks prior to the vaccine.
4 weeks after getting the second vaccine, I am experiencing extreme fatigue and dizzy spells.  Had a consultation with doctors on demand and she feels it is associated with getting the covid vaccine
gave Infanrix instead of Tdap to two 7 year old twin siblings; she inadvertently gave Infanrix instead of Tdap; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (Infanrix) (batch number 7p9nj, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included DTPA-IPV-HIB (received 1st dose on 30-JUL-2016), DTPA-IPV-HIB (received 2nd dose on 23-NOV-2016) and DTaP vaccine (received one DTap on 26-SEP-2016).   On 18-OCT-2023, the patient received Infanrix. On 18-OCT-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: gave Infanrix instead of Tdap to two 7 year old twin siblings) and wrong vaccine administered (Verbatim: she inadvertently gave Infanrix instead of Tdap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2023 Registered nurse reported that she inadvertently gave Infanrix instead of Tdap to two 7 year old twin siblings yesterday as part of catch-up. The patients were in the schedule, nurse reported the first patient received 1st dose was DTaP/Hepatitis B/IPV on 30-JUL-2016, the 2nd dose was DTaP, Hib, IPV on 23-NOV-2016, and then one (DTaP but didn't mention if it was in combination with other components) on 26-SEP-2016. The 7 years old patient received Infanrix instead of Tdap, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. Didn't clarify brand name of previous doses. This case had been linked with US2023145262 , reported by the same reporter for 2nd patient.; Sender's Comments:  US-GSK-US2023145262:Same reporter, 2nd patient
First dose, Received: 06Apr2022/Second dose, 02Jun2022; Swollen tongue; has affected her speech and she speaks slowly; having a little bit of problem swallowing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 2, single (Lot number: FM7553) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose:, Lot Number: FK9893), administration date: 06Apr2022, for COVID-19 Immunization, reaction(s): "Swollen tongue", "has affected her speech and she speaks slowly", "having a little bit of problem swallowing". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "First dose, Received: 06Apr2022/Second dose, 02Jun2022"; SWOLLEN TONGUE (non-serious), outcome "not recovered"; SLOW SPEECH (non-serious), outcome "not recovered", described as "has affected her speech and she speaks slowly"; DYSPHAGIA (non-serious), outcome "unknown", described as "having a little bit of problem swallowing".  Additional information: Caller is a consumer that was calling for side effects after receiving her vaccine. Caller clarified that she was calling about the Pfizer Covid-19 vaccine.  She reported that she had a swollen tongue and is still experiencing it. It has affected her speech and she speaks slowly. The tip of her tongue feels swollen and she is having a little bit of problem swallowing now.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200961565 same product, different dose and event;
Patient received the Pnuemovax 23 injection in the left shoulder joint instead of the Deltoid muscle.  A few hours later patient had severe pain and could not move his left arm.   Pain was so severe that patient went to Urgent Care the next day.  Pain and loss of mobility continued so patient saw their primary doctor's physician's assistant and received pain meds.  Patient still has pain and still cannot move his left arm.
Patient was very weak, had a hard time getting out of the bathtub the next morning. Could not turn over on the couch due to weakness. His legs felt rubbery. This all lasted one day and he felt 90% better the next day.