chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jynneos administered intramuscularly; Case reference number US-BN-2022-001857 is a spontaneous case report initially received from a nurse via Bavarian Nordic on 09-Aug-2022 and concerns a patient of unknown demographics (eighth out of nine).  The patient's medical history and concomitant medication details were not reported.  On an unspecified date, the patient was vaccinated with a dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: not provided) intramuscularly (IM), at an unknown dose or site of administration, for unknown indication (explicitly coded as 'Inappropriate route of vaccination').  At the time of this report, it was unknown whether the patient experienced any adverse event due to Jynneos.  Additional information received from Bavarian Nordic on 11-Aug-2022 included the country of occurrence.  Additional information received from Bavarian Nordic on 12-Aug-2022 included the local case ID.  This case is linked with cases no. US-BN-2022-001839, US-BN-2022-001851, US-BN-2022-001852, US-BN-2022-001853, US-BN-2022-001854, US-BN-2022-001855, US-BN-2022-001856 and US-BN-2022-001858, concerning the same reporter.; Reporter's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: The patient of unknown demographics was vaccinated with a dose of Jynneos, intramuscularly (IM), at an unknown dose or site of administration, for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
A few days before she had trouble breathing, wheezing and then  she got the vaccine and it got worse.  Also had pains in her legs and chest.  She gets weak and would have to lay down a walk and when she goes up and down the steps had to huff and puff, which she had not have this type of trouble in the past.  She went to her cardiologist who took blood work, and he also did a chest x-ray.  She then went to her PCP last week, who said he would check with her cardiologist and see the results of his tests.  She is also a little light headed, but the breathing and wheezing is what is most bothersome.
Information has been received from a physician concerning a 19 year old ,male with no drug allergies and a history of familial risk factor (at birth mother had positive hepatitis B surface antigen) who on 01-MAY-1990 was vaccinated with MERUVAX II. The physician reported that the patient recently (dates not specified) tested negative for rubella titer. No problems were reported. Additional information has been requested.
Pt vaccinated with Engerix-B developed dizziness, nausea, arm felt heavy.
Itchy, started within 15 minutes of the injection; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 at 13:15 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension and panic attacks. The patient had a history of allergy to sulfur. The concomitant medications were reported as no. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 05Mar2021 at 08:45 (at the age of 67-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Mar2021 at 13:30, the patient felt Itchy and it started within 15 minutes of the injection. No treatment was received for the reported events. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchy was not recovered at the time of reporting.   Information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes; Painful lymph nodes; Pain at injection site; Black and blue torso; This case was reported by a consumer via call center representative and described the occurrence of enlargement of lymph nodes in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a day after receiving Shingrix, the patient experienced enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration. On an unknown date, the outcome of the enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the enlargement of lymph nodes, lymph node pain, injection site pain and skin discoloration to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received Shingrix vaccine into the left arm about 5 months ago.  Shortly after getting the vaccine, her left torso became black and blue which lasted for 2 weeks. On the day of vaccination, she experienced swollen and painful lymph nodes that lasted for one week.  The patient also experienced pain at the injection site that lasted for one day. The patient provided the consent to follow up.
This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced just did not feel right, and feeling of malaise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from just did not feel right, and feeling of malaise. This report was non-serious.
Malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0167, Expiration Date: Feb2025), Device Lot Number: F831, Device Expiration Date: 01Aug2027. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece".  The reporter considered "malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece" associated to device constituent of rsv vaccine prot.subunit pref 2v. Causality for "malfunction with the bottles with the part that when screw on the adapter the syringe popped out of this piece" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Additional information: The pharmacist reporter called about about 2 bottles of Abrysvo vaccine malfunctioned and wanted to replace them. Reporter confirmed both bottles had the same lot details for all the components (the carton, vial adapter, antigen vial, and diluent syringe). The pharmacist clarified that the malfunction as the part that when screwon the adapter the syringe popped out of this piece (occurred for both bottles). The reporter stated that Abrysvo bottles that malfunctioned was not administered to any patient. Reporter got a third one out to use and that one worked.   The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
chill; tired; Unwell; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 99-year-old female patient (reporter's Mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter mentioned his mother experienced side effects unwell, chill, tired on an unspecified date and asked if his mother can take Tylenol. Outcome of the events was unknown.  Information on the Lot/Batch number has been Requested.
Patient received PREVNAR 13 on 10/31/16 at other facility. Three days later patient was hospitalized with acute joint pain, dizziness, sweating and being treated for pneumonia.
Swollen arm; This is a spontaneous report received from a contactable consumer (patient's husband).  A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Feb2021 in the afternoon (Batch/Lot Number: EL9266) as single dose at the age of 72-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swollen arm in Feb2021 for about 12 hours after the first vaccine it might have been the next day. The events were considered non serious. The outcome of swollen arm was completely recovered after about 12 hours in Feb2021. A product complaint to report was filed.  No follow-up attempts are needed. No further information is expected.
Night of 26th: Extreme soreness at injection site; unable to use left arm for anything that required contraction of that muscle; increasing headache and muscle aches Morning of 27th:  Continued soreness at injection site and in that muscle; increasing muscle & joint aches; difficulty in performing daily tasks due to aches; headache Night of 27th: Severe aches in muscles and joints; very strong headache; low grade fever of 99.1 Morning of 28th: lessening of muscle & joint aches; lessening of injection site soreness; continued strong headache Night of 28th: minor muscle & joint aches; regained ability  to use left arm; headache gone after taking 2 extra strength acetaminophen in the afternoon
Information has been received from a nurse concerning a female between teh ages of 13 to 16 years old with no prior history of drug reactions, who was vaccinated intramuscularly with the second dose of Gardasil (lot # 654741/1208F). On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of Gardasil, the patient fainted. Subsequently, the patient recovered from the fainting. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided, if available. The same source provided information on another patient, WAES #0707USA01794 and WAES # 0709USA00163.
Numbness rt  hand,arm,face. Unable to speak. Difficulty swallowing.     Diagnosis TIA.  Now on plavix and Lipitor.
Client with aches, fever starting within several hours of receiving vaccine on 5/3/2021. Those side effects resolved the next day.  Within 24 hours of receiving vaccine,  client with red raised area warm to touch on left arm surrounding injection site.  Client also reports swollen lymph nodes in neck region.  Informed client that swollen lymph nodes are listed and that there have been reports of redness at injection site and to contact PCP for any care related to side effects of vaccine.
She has continual UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient in her 70's received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: URINARY TRACT INFECTION (non-serious) with onset 2021, outcome "not recovered", described as "She has continual UTI". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received both doses of the Pfizer-BioNTech Covid-19 Vaccine 7 and a half months ago. She said her husband, who previously had covid 10 months ago, also received both doses and his antibodies was around 20. After both immunizations, she said she was told to wait for a period of time for the vaccine to begin to work fully in their bodies. With that, she wants to know how long it takes for the booster dose to take its effect in the body. She wants to know if the future Pfizer booster doses would also take the same time to be effective in the body compared to the booster dose that is available now. Consumer also mentioned that she is disabled, and has medical issues. She said she is currently taking medications. She said she has continual UTI that she had been trying to treat but it's not working. She also mentioned that she is in contact with a hematologist. She said she can't even get herself a glass of water. Responded from the attached, CONS-booster dose (v13.0) and CONS-when does the vaccine start protecting me against covid-19 (v5.0).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reported today that the injection site on her left arm where she received the vaccine still hurts. It hurts whenever she uses her arm. When she touches the site it feels like the needle is still embedded in her arm and she gets a tingling sensation in the fingers of her left arm. She developed a rash at the injection site about a week after receiving the vaccine , but the rash has since gone away. However the pain still remains in her arm.
Broke out I hives, seen MD in ER and he gave me solu-medrol and benadryl injection
Pt. came into pharmacy on 5/23/16 C/O general pain in her arm where the ZOSTAVAX inj was given on 4/18/16. She wasn't sure if it was actually from immunization of it she hurt her arm. Pt was also referred to MD.
Fever (100.7), vomiting, nausea, diarrhea, near Syncope, dizziness, redness and swelling size of baseball to left arm (injection area), hot to touch, and tenderness.  Missed two days of work from symptoms.
rose spot rash on trunk, constipation, sl h/a occurred p/last capsule ingested several hrs p/uncertain of exact time;
Within hours upper arm pain at site of injection.  Small lump turned into large size lump that was hot and painful to touch and slowly same evening I began having pain lifting that same arm.  Very painful and had a hard time sleeping.  Within 24 hours the pain subsided.  I also had nausea and muscle aches next day but those subsided within 24 hours as well.  4 days later I awoke with a rash and raised ring around the injection site.  About the size of a tennis ball.  Rash subsided within 24 hours.  Documented with pictures.
Patient received unintended overdose (1.8mL) of Pfizer Bivalent Booster dose, as well as correct doses of Menveo, Tdap and influenza vaccines.  Sore arm reported a few hours later.  Overnight, the patient reported fever, body aches, severe headache, cough, and sore throat. Patient was self-treating with tylenol and ice packs on arm.  Symptoms became progressively better over the weekend.  By 9/19/22 patient reported arm was still sore, but other symptoms had improved.  Patient was monitored by staff primarily via phone calls and emails.  RN made one visit on 9/17/22 to deliver thermometer and visually check on patient.  Patient denied need to go to ER at that time.
Headache in forehead area with light sensitivity, one Motrin pill taken 12:30 pm then sleep, awoke with mild headache, one Motrin pill taken 01:30 am.
Approx. 24 hours after immunization administered, a red, swollen rash appeared at site on left upper thigh. Zyrtec given.
mom noted ras on chest  initially changed a little to blisters on chest,behind legs and arm
Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYALGIA (Sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-161828, MOD-2021-161828 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: On 24-may-2021, Pictures of the vaccination card and events caused due to vaccination were attached .
fluttering in ears like there is a bug going inside; numbness of the roof of her mouth; This is a spontaneous case received from a contactable consumer (patient himself). A 51-year-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FD8448), via an unspecified route of administration in left arm on 20Aug2021 13:00 (age at vaccination 51-year-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient's family medical history relevant to adverse event was reported as none. The patient historical vaccination included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: CU3399), via an unspecified route of administration in left arm on 27Jul2021 13:00 (age at vaccination 51-year-old) for COVID-19 immunisation. Additional vaccines administered on same date of the Pfizer suspect was reported as none. Prior vaccinations within 4 weeks were reported as none. Adverse events following prior vaccinations was reported as none. On 20Aug2021, the patient experienced fluttering in her ears, like there is a bug going in her ears and numbness in the roof of her mouth. He experienced both symptoms mentioned within 45 minutes of the second dose. He was having the symptoms right now. Adverse event does not require a visit to Emergency room/Physician office. The outcome of the events was reported as not recovered.  Follow-up attempts completed. No further information expected.
Adverse event onset after administration of MMR vaccine sq edema and redness. Pt was evaluated by doctor.
Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunodeficiency (the patient's immune system was compromised).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination as not reported. The patient had both Shingles vaccines several years ago and experienced shingles. The patient was recovering now. The physician told him it was a 1 percent chance of getting Shingles if you had both shots.  The follow-up would not possible as no contact details were available. The case was considered as suspected vaccination failure since the detail regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Relapsing polychondritis three times/ affects the cartilage and its in the ears; This spontaneous case was reported by a consumer and describes the occurrence of POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A. and 026L20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR), ATORVASTATIN CALCIUM (LIPITOR), METOPROLOL, ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS] and CHONDROITIN SULFATE, GLUCOSAMINE HYDROCHLORIDE, MANGANESE ASCORBATE (COSAMIN) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) (seriousness criterion medically significant). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse event, at a dose of 20 mg for 10 days and MOMETASONE for Adverse event, at a dose of 0.1 crm. At the time of the report, POLYCHONDRITIS (Relapsing polychondritis three times/ affects the cartilage and its in the ears) had not resolved.            Patient was first time treated with cortisone and antibiotics, second time with an oral antibiotic and cortisone cream, third time with prednisone and a cream Mometasone .  Patient had relapsing polychondritis three times since 09 MAY 2021. Patient had experienced  the first two relapsing in the left ear where several weeks were passed between these two episodes and the last episode occurred in the right ear and it was reoccurring. Patients previous doctor thought it was eczema but ENT diagnosed it as relapsing polychondritis.  Based on the current available information and temporal association between the use of the product and the start date of the event relapsing polychondritis, 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 event relapsing polychondritis, a causal relationship cannot be excluded.
Leg swelling, redness, warmth, pain, low grade temp 99F. Tylenol and Ibuprofen, cool compress.