chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnant at the time of vaccination; Swollen lymph nodes/ painful swollen lumps; Shingles/ pustules on my head and neck; The pain progressed over the course of a week before it became unbearable; prevented her from daily activities including work; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: ER8737) via an unspecified route of administration, administered on the left arm on 29Mar2021 19:00 as 1st dose, single for COVID-19 immunization. Medical history included dermatomyositis, antisynthetase syndrome and Sjogrens syndrome. Concomitant medications included metformin; insulin glargine (BASAGLAR); hydroxychloroquine and levothyroxine sodium (LEVOTHYROX). The patient previously took azathioprine and experienced allergy. Patient was pregnant at the time of vaccination. Within hours, patient developed painful swollen lumps and pustules on my head and neck, later diagnosed as swollen lymph nodes and shingles on 30Mar2021 04:00. The pain progressed over the course of a week before it became unbearable and patient was treated at ED and given antiviral for shingles. She is on DAY 16 and the pain from the swollen lymph nodes still prevented her from daily activities including work. The events resulted to a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. Treatment received for the events in the ED included morphine drip and acyclovir RX. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19: Nasal Swab test: negative on 06Apr2021. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 24 Weeks pregnant at the onset of the event. The mother was due to deliver on 17Jul2021. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Severe shoulder joint pain. Injection site located over left shoulder joint instead of over muscle. Pain began two hours after injection, with dull pain while motionless and sharp pain with movement of the shoulder joint or while bearing weight. Pain subsided over several days, but slight pain and arm weakness has persisted for 6 weeks with occasional flares after excessive usage or stretching. Treatment has consisted of cold compresses, ibuprofen, and acetaminophen. Symptoms have not yet resolved.
Blurred vision Narrative: Referred to ophalmology for dilated eye exam. Has h/o exposthalmos, glaucoma, lense replacement
Shortness of breath, extreme fatigue and muscle weakness, rash on both arms, dizziness, sensation of chest compression, head ache, slight nausea
Noticed pain last night. This morning a little red but redness has gotten worse Lt arm discomfort in arm. Able to raise arm. Not feeling well. Seened by PAC needs to elevate Lt arm, use ice, ibuprofen or ALEVE. Flu on 12-20-13. Lt arm better, decreased redness, decreased swelling.
Redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th July 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient had her first Shingrix vaccine on Wednesday earlier to the date of reporting in the left upper arm. On Thursday earlier to the date of reporting, the patient noticed redness of about 10 inches in size but to the side of the injection site.  The patient noted the redness was decreasing but wanted to know if this was a common side effect. The reporter did not gave permission to follow up.
accidentally given a Pentacel and an ActHIB vaccine on the same day with no adverse event; Initial information received on 10-Nov-2020 regarding an unsolicited valid non-serious case from  a other health professional.  This case is linked to case 2020SA317690.  This case involves a 1 years old male patient who experienced accidentally given a pentacel and an acthib vaccine on the same day (extra dose administered), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not provided.  On 10-Nov-2020, the patient received a 4  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ160AAA via intramuscular route in the left thigh for prophylactic vaccination.  On 10-Nov-2020, the patient developed a non-serious accidentally given a pentacel and an acthib vaccine on the same day (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE..  No laboratory data was provided.  No corrective treatment was received.  The event outcome was reported as not applicable for extra dose administered, at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I am in pain; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Flu vaccine, reaction(s): "Sick", notes: She had taken the flu vaccine 4-5 years ago and felt very sick.; Advil, reaction(s): "GI issues", notes: Can't take Advil due to GI issues. The following information was reported: PAIN (non-serious), outcome "unknown", described as "I am in pain".  Additional Information: The patient stated "I am in pain. I don't know what to do".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The ordering Physician ordered Menactra and Hep A to be administered to patient. MAS administered immunizations as ordered. MAS explained to pt and mother the vaccines that were to be given, and than administered vaccines. Patients mother spoke to clerk when checking out and said patient already recieved Menactra and was soppose to recieve HPV vaccine instead. Provider was notified as well as administrator. Dr. spoke to patient and family and gave the HPV vaccine.
Patient presented for first Pfizer vaccine.  Pt was held but twisted as vaccinator gave the vaccine and needle was withdrawn.  0.1 ml (half) of vaccine left in vial, vaccinator reports some vaccine ran down arm and therefore patient received less than 0.1 ml.  Vaccine administered in opposite deltoid as ordered, specified with management and lead pharmacist.  Pt was not bleeding, no adverse effects noted.  Pt received vaccine as ordered, received full dose.
Redness, warmness, red whelps. Pt informed to take BENADRYL, pain reliever/fever reducer and apply cool compresses.
Received MMR-V, DTaP-IPV, and Hepatitis A all on R deltoid during office visit 2 days ago, presented with 1.5 days of expanding erythema/edema/warmth and tenderness on R deltoid/upper arm. Afebrile, no fever by history, no n/v. Possible large local reaction to vaccines, however as with typical presentation of cellulitis, treated with cephalexin QID x 7 days.
bumpy; rash at the injection site that has growth to about softball size; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size). At the time of the report, VACCINATION SITE MASS (bumpy) and VACCINATION SITE RASH (rash at the injection site that has growth to about softball size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. On 12 APR 2021 patient noticed a rash at the injection site that has growth to about softball size and was bumpy. Patient stated there was a line from the injection site to his chest where there was a second rash the size of a quarter. Reporter stated the patient has had no treatment.
Redness and swelling of upper left arm extending past the shoulder proximally and to nearly the elbow distally. No fever, resolved within 4-5 days. No antibiotics needed.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in right arm for Covid-19 immunisation; enalapril maleate (ENALAPRIL MALEATE), (Batch/Lot number: unknown); latanoprost (LATANOPROST), (Batch/Lot number: unknown). The patient had no relevant medical history. Concomitant medication(s) included: TIMOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Product: COVID-19. Treatment, Brand: Paxlovid, Treatment start date: 04May2022, Treatment stop date: 08May2022, Indication: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; Negative; positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Left arm got a hard knot under the skin, about the size of a half baseball. The site became warm, and remained for four to five days. It is now eight days post injection with only a little of the hardness left at the injection site. I realize that this was not a dangerous reaction, but I am reporting as it might be for the next person. As a further point of clarification, I showed the result to a friend (Dr.), who advised ice if needed on the site. As he was not worried, it also made me less apprehensive.
My daughter woke up as she normally did and fussed for a bottle. Her father went downstairs to get a bottle and warm it up. Upon returning to her crib he found her limp and unresponsive with the whites of her eyes turned pink. He tried to get a response from her by tickling her feet but got no reaction. Her father then called 911 where she was taken to the hospital. Upon arriving at the hospital she had suffered a stroke. She was put on an aspirator then flown by helicopter to another hospital. Upon my arrival to the hospital I was told that she had suffered from a subdural hematoma and that 90% of of these cases with this kind of damage was because of shaken baby syndrome. My daughter had NOT been harmed by ANYONE that she came in contact with. Because of her injuries her father and I are being investigated for child abuse, especially her father since he was alone with her that day. That day the state took custody of her and made us leave the hospital. Determined to find out how this happened to her we searched the internet where we came across articles written by doctors who have had cases where the parents were accused of abusing their child(ren). Most of these children had died from a subdural hematoma and an autopsy was done on these children. I the brains of these children were toxins from the pertussis vaccine which was given to them a week or less before they had died. It was exactly one week after receiving the DTaP vaccine that my daughter suffered the subdural hematoma. Also, her neurologist claimed that there were signs of old damage to her brain, and being only two and a half months old at the time and as well as only receiving the DTaP vaccine one week prior, I believe that the hepatitis B vaccine she received on the first day she was born may have played a part in her condition. (In my research I had found that the hepatitis B vaccine can mimic shaken baby syndrome). In addition to her subdural hematoma and stroke, her brain began to swell (which is another reaction to DTaP that I found) and seizures. Also, prior to this happening, she was having some vomiting issues and was taken to the doctors who found no explanation for her vomiting. My daughter is recovering very quickly and will be released from the hospital very soon, but to a foster parent and not us. It is assumed she will have problems because of this.
HIGH FEVER PER PT, LAUGHING, CRYING, TALKING NONSENSE, BODY WEAKNESS, GENERALIZED PAIN.
sore throat, hoarseness, h/a, t99-101; seen by MD was told URI; sx lasted 7 days;
By end of day pt c/o pain in (L) brachium which continued post injection which continues to present date.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M006708, expiration date 02-JUN-2018, route unknown). The vaccine had been stored under 50.9 Fahrenheit for 34 minutes. There was no previous exposures. Digital data logger had been involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 63 year old female patient with type 2 diabetes mellitus, osteoarthritis, "HT" body mass index increased, "DOD" and LEVAQUIN allergy with a history of recurrent shingles following prior vaccination who on 26-MAR-2010 was vaccinated with a SQ dose of ZOSTAVAX (Merck) (Lot# not reported), into the arm. The physician stated that on 20-APR-2010, the patient experienced acute herpes zoster post vaccination. It was unspecified if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
While in waiting area had asked for something to drink and couldn't drink water, chills and weak. Escorted to treatment room complaint of dizziness. Vital signs monitored and assessed patient while in room.
diaphoretic, hypotensive,  dizziness skin: pale.  Diphenhydramine 12.5mg oral 1x given. time Course 10:46 of initial injection to 10:10 am
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
Vision was distorted for about a half hour to an hour; Vision had changed and she wasn't able to see very far; This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. EW0153) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far). On 10-Apr-2021, METAMORPHOPSIA (Vision was distorted for about a half hour to an hour) and VISUAL IMPAIRMENT (Vision had changed and she wasn't able to see very far) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Severe sore throat, flu-like symptoms, severe cough, breathing difficulty, pneumonia of left lung. Admitted to hospital 11/14/01; discharged 11/24/01. Readmitted 11/25/01 and discharged 11/30/01. The discharge summary states congestive heart failure, and hypernatremia. Annual follow up on 01/28/04: "Pt died on 03/25/03, unrelated to vaccine."
This spontaneous report was received from a registered nurse via a company representative and refers to a female adolescent patient (specific age was not reported). No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date (reported as a couple of months ago), the patient was vaccinated with GARDASIL 9 injection (dose number, dose, route of administration, lot# and expiration date were not reported) for prevention of Human Papilloma Virus. After vaccine administration, the patient's mother did not want to wait 15 minutes before leaving. As the patient's mother was leaving with the patient, the patient fainted at the front desk and hit her head. The reporter stated that the staff looked at the patient's head and determined that there was no serious injury or medical attention needed. No treatment was given for the adverse events. The outcome of the adverse events was not reported. Causality assessment was not provided.
Initial report was received from a consumer, who was also the patient, on 07 March 2013. A female patient (age and date of birth not reported) had received an INFLUENZA VACCINE (manufacturer, lot number, route, site and date of administration not reported) in January 2013. On 14 February 2013, the patient experienced low grade fever, vomiting, diarrhea for which she was admitted to the hospital. Treatment included IV fluids. She was diagnosed with "the flu" when in the hospital. By 15 February 2013, the patient started to "keep food down". On 16 February 2013, the patient was discharged. Symptoms completely resolved and has had no further problems. The patient had no illness at the time of vaccination and a history of MS. Outcome was recovered. Documents held by sender: None.
Sore arm; lump in lymph node under arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Mar2021 as dose 2, single (Lot number: EN6204), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago; "mastectomy" (unspecified if ongoing), notes: Breast cancer resulting in mastectomy 7 years ago; "SVT (Supraventricular tachycardia)" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1 Batch/Lot No: EL9269 Location of injection: Arm Right), administration date: 13Feb2021, for COVID-19 Immunization, reaction(s): "lump in lymph node under arm", "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "lump in lymph node under arm". Therapeutic measures were not taken as a result of pain in extremity, lymphadenopathy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201387339 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373767 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373781 Same Reporter/Patient, Different AE/Vaccine Dose;PFIZER INC-202201373782 Same Reporter/Patient, Different AE/Vaccine Dose (LOE case);
A 34 year old female pt exposed to a bat developed severe abdominal pain, headache, and generalized sickness after each injection of RabAvert.  The pt received three doses of RabAvert 1mL IM.  The pt was exposed to a bat that was in the stroller of her child.  The animal escaped and the pt was started on the post-exposure RabAvert series.  With each of the three injections she experienced increasing abdominal pain, headache, and generalized sickness. She refused additional treatment with RabAvert.  Her rabies virus antibody titer after the third injection was 2.5IU.  No other information was provided.
Upper left arm, at site of injection:  red, swollen, itching.  Size = 3.5 inches x 2.5 inches.
This spontaneous report was received from a physician via a company representative and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On an unknown date, the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscularly for cervical cancer prevention (lot number and expiration date were not provided). It was unknown if it was the patient's first, second or third dose of the vaccine. On an unknown date in 2017 (reported as 6 to 12 months ago), the patient experienced tingling down her left leg. It was reported that the event was probably not a result of an overdose. Treatment and event outcome of the event were unknown. The relatedness between the event and GARDASIL 9 was not provided.
Information has been received from a registered nurse concerning a 12 month old female who in approximately 2007, about one year ago, was vaccinated subcutaneous with a 0.5 ml VARIVAX (Merck). About two weeks post vaccination, the patient developed a mild case of chicken pox. The symptoms included a low fever and about 15 total lesions. At the time of the report, it was unspecified if patient sought medical attention and the patient outcome was unknown. Additional information has been requested.