chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; Anatomical site of vaccine administration: Left Arm, There was really tender; Anatomical site of vaccine administration: Left Arm, swelling on the arm like a hard notch/My arm is swelled up; felt feverish; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL8982), via an unspecified route of administration on 13Jan2021 at SINGLE DOSE (first dose, left arm) for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date. The patient's concomitant medications were not reported.  The patient received the first dose of the vaccine on 13Jan2021. Anatomical site of vaccine administration was the left arm. The patient experienced a reaction afterwards which made her miss 2 days of work and work with her patients as she do home care (Jan2021). She experienced swelling on the arm like a hard notch/arm is swelled up and felt feverish and by the next day she could not move her arm at all/move her arms up the following day. She reported that there was really tender. She was supposed to get the 2nd dose of the vaccine on 03Feb2021 and was asking if she can take it on the 05Feb2021 so as she cannot miss work in the event, she experiences the reaction again. No Physician Office/ Emergency Room visit involved. Treatment included Tylenol to help with the pain and then put ice on it to break it keep swelling down. Outcome of the events was unknown. The case was reported as non-serious.
4 hours post vax, pt complained of lower back pain over both kidney areas. 3 hours later, all joints and muscles hurt and it was difficult to breath.  Symptoms gradually became worse. Saw doctor at office and had a fever. Physician diagnosed light case of flu and prescribed Advil and Tylenol. Symptoms lasted for 2 1/2 days.
Patient received Janssen COVID-19 vaccine on 03/06/2021.  Patient came in to pharmacy on 06/29/2021 and received 1st dose of Pfizer COVID-19 vaccine.  Patient came back to pharmacy on 07/20/2021 for 2nd dose of Pfizer.  Upon talking to patient and discussing history of Janssen vaccine, we denied giving the patient the 2nd dose of Pfizer until official recommendations have been updated.
Knocked her out; Chills; Sore arm that is painful when you move it; In the bed for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Knocked her out), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (In the bed for 4 days), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm that is painful when you move it) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Knocked her out), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (In the bed for 4 days), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm that is painful when you move it). At the time of the report, FEELING ABNORMAL (Knocked her out), CHILLS (Chills) and VACCINATION SITE PAIN (Sore arm that is painful when you move it) outcome was unknown and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (In the bed for 4 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient was not on any medication aside from vitamins but was supposed to be on a baby aspirin.  No treatment drugs were reported   This case was linked to MOD-2021-419718, MOD-2021-419795 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Dec-2021: Follow-up information received included non-significant information.
This case was reported by a physician via call center representative and described the occurrence of cold sore mouth in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included cold sore mouth. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, several days after receiving SHINGRIX, the patient experienced cold sore mouth. On an unknown date, the outcome of the cold sore mouth was unknown. It was unknown if the reporter considered the cold sore mouth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Few days after receiving SHINGRIX, the patient experienced oral cold sores. The healthcare professional did not have access to any patient. The healthcare professional did not have access to any vaccine information at this time. The healthcare professional stated he could call back with the information later if needed.
pain in her feet; a sensation of heat.; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her feet"; FEELING HOT (non-serious), outcome "unknown", described as "a sensation of heat.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 4 months after vaccine, I had an unusual bruise show up on my vaccine site with a lump. It was pain free so like a regular bruise that didn't hurt even when I pushed on it. It wasn't going away after a week, and it wasn't changing size or shape, and it was dark blue in color. I was seen and the doctor felt like it could or couldn't be related to the vaccine but wasn't sure. A week later, rather than healing, it started to drain in the top half and 2-3 days later the bottom half drained. I have a faint bruise right there, and it took about two weeks to heal, and it was just an inexplicable bruise, and it wasn't painful and it was just super unusual that it was in the exact spot where I had the vaccine. It's still there but it's not as bad, only an outline.
Patient presented with a non-itching, non-hurting red rash and swollen lower left bicep
Following the first, I got a respiratory illness for over a week. Following the second, I could barely walk and have not had a menstrual cycle since. I have missed my last 3 cycles. I have NEVER had an issue or missed before. I received 2 blood tests and was not pregnant, and neither show any reason to have missed it.  I have no health issues, I am healthy, I just turned 36, have 2 healthy kids, exercise daily and eat properly. The only explanation for missed cycles would be the moderna shots I received.
AFTER ADMINISTRATION OF J&J 1ST DOSE OF VACCINE, @1742, PT'S FELT LIGHTHEADED, SWEATY, HELPED PT'S TO SIT ON THE FLOOR WITH WALL SUPPORT ON HIS BACK, HAD WATER ~@1743. CHECKED PT'S BP DROPPED TO 86/52 MMHG, PULSE 40/MIN ~@1745. Pt's SATRTED FEELING BETTER, CHECKED BP AGAIN ~@1755 BP 120/75 MMHG, PULSE 55/MIN. ~1804 PT'S FELT WAY BETTER AND THOUGHT HE COULD GO HOME, PT'S ASKED TO SATY ATLEAST 30 MINUTES IN OBSERVATION. PT'S LEFT ~1819 PT'S FEELING BETTER LIKE NOTHING HAPPENED. DP 12/27/2021 @1825
Weakness, muscle pain in site of injections, muscle pain in legs, fever that went as high as 102.3 and lasted 2 days.  Fever was highest on the evening of 5/21/2011 and returned to normal on morning of 5/23/2011.
Information has been received from a nurse practitioner concerning a patient who, "about a week ago", on approximately 22-OCT-2007, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought. Subsequently, no adverse events were reported. No product quality complaint was involved. Follow-up information has been received from the office manager who confirmed that one female patient was given varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No other details were available at the time of this report. Additional information has been requested.
Information has been received from a health professional concerning a 7 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the patient developed mild breakthrough varicella. It was unknown if medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
headache; This is a spontaneous report received from contactable consumer(patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he had a headache for just one day and didn't take anything. It was reported that, On Sunday he was getting the second dose. Patient filled this big sheet out at the facility and put that he had a headache, it was at the facility. Patient got a letter from the facility, and they really handled the vaccination process well. Even the bosses were there. Patient queried for If Tylenol, never worked on him. Can you take anything stronger If I get a headache. The outcome of the event was unknown.   Information on the lot/batch number has been requested  Follow-up attempts completed. No further information expected.
FOLLOW UP INFORMATION CONTAINED additional safety information from the physician regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced vaccination site swelling, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm, right thigh with 2 small area that were warm to touch and firm, listlessness and fever. The patient received a dose on 14 Jun 2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on 14 Jun 2010. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced vaccination site swelling on 14 Jun 2010, rash in buttocks, approximately 20 red papules all small, acting a little less energetic than usual, right thigh with 2 small area that were warm to touch and firm, local allergic reaction to vaccine, impetigo, right thigh with 2 small area that were warm to touch and firm and right thigh with 2 small area that were warm to touch and firm on 15 Jun 2010 and listlessness and fever on 16 Jun 2010. Patient was treated with BENADRYL and TYLENOL for the hypersensitivity and KEFLEX oral suspension for the impetigo. The outcomes of the events were not reported. TEST RESULTS: Body temperature (results: 99.1 deg. F.) was done on 15 Jun 2010. Additionally, physical examination (results: normal) was done on an unspecified date. No additional information was available at the time of this report.
Injection site pain and swelling Narrative:  Pt called COVID-19 Vaccine ADR hotline reporting L arm swelling and soreness on 2/8/21 after receiving his second dose of the Moderna Vaccine. Denies any other swelling, SOB, or rash/hives. Pt reports taking acetaminophen, applying ice and Bengay cream to the area and has noticed much improvement now on 2/9/21. Pt instructed to inform PCP, and if he experiences any severe sx to seek immediate medical attention.
My son developed a fever ranging from 99 degrees Fahrenheit to 102.7 degrees Fahrenheit on the same evening after receiving the hib, IPV, Dtap vaccines.  The fever continued in that way for exactly six (6) days.  On the fourth day, I took him to his pediatrician who examined him, and determined that he could not conclude what exactly was wrong with my son, and to return if the fever was 106 degrees Fahrenheit or more, or if the problem persisted past 14 days.  On the fifth day, my son developed diarrhea, which still persists to date. Exactly seven (7) days after his vaccination, my sons fever subsided only to be replaced with a red raised rash that covered his face, neck, back, chest, pubic area, and buttocks. I have made another appointment for my son to see his pediatrician this afternoon.
Even more achy for two days; Even more achy for two days, she could not get out of bed.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Even more achy for two days) and ASTHENIA (Even more achy for two days, she could not get out of bed.) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    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, the patient experienced PAIN (Even more achy for two days) and ASTHENIA (Even more achy for two days, she could not get out of bed.). At the time of the report, PAIN (Even more achy for two days) and ASTHENIA (Even more achy for two days, she could not get out of bed.) outcome was unknown.            Treatment information was not provided. Patient took allergy pill some herbal medications.   This case was linked to MOD-2021-402862, MOD-2021-398618 (Patient Link).
Approx 54 hours after vaccination, the lymph node in my left armpit swelled up to the point it was painful and relatively uncomfortable. My arm was no longer sore at the injection site, but I was unable to lie on that side while sleeping in bed. I took 600mg of Ibuprofen every 6 hours to help with the pain and swelling. It has subsided some, but is still swollen.
Shoulder pain in left arm resulting in hindrance in range of motion and usage. Cannot lift left arm or perform small circular movement. Cannot perform basic usage such as opening a door or lifting a small object. Other symptoms reported are fever, muscle aches, and fatigue.
In June, chicken egg and garlic anything fried, chocolate and peanut butter, pretty much anything with protein I couldn't eat it or smell it. It smell it gross and it was something I couldn't be around. I went to a doctor and they couldnt do much. They did blood work and they put me on a stomach acid reducing pill and nothing really changed. It has decreased, but things with protein have.  my bf has the same symptoms but he got pfiser and i got moderna.
No adverse event; Patient received 0.25 mL doses instead of 0.50 mL of bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 21-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received 0.25 mL doses instead of 0.50 mL of bivalent).    No concomitant medications were reported.  It was unknown if patients reported any adverse events or not.  No treatment medications were reported.   This case was linked to MODERNATX, INC.-MOD-2022-663507, MODERNATX, INC.-MOD-2022-663578, MODERNATX, INC.-MOD-2022-663474 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-663578: MODERNATX, INC.-MOD-2022-663474:Same reporter MODERNATX, INC.-MOD-2022-663507:
This spontaneous report as received from an administrator refers to a 12 month old male patient. The patient's pertinent medical history included anorectal malformation. No drug reactions/allergies and concomitant medications were reported. On 07-FEB-2019 the patient inadvertently received a dose of PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) instead of PREVNAR 13 (dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. The patient had not received any treatment for the event. No lab diagnostics/studies were performed. No product quality complaint was involved.
received his routine doses of MENACTRA but declined to receive a booster in high school prior to college, with no reported adverse event; Initial information received on 12-Jul-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old female patient who received his routine doses of Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra] but declined to receive a booster in high school prior to college, with no reported adverse event.  The patient's past medical history included Cancer (Neoplasm malignant) in 2018, underwent radiation (Exposure to radiation) and stem cell transplant. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received his routine doses of menactra but declined to receive a booster dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine (Solution for injection) (dose; frequency; lot; strength and expiry date not reported) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date the patient received his routine doses of Meningococcal A-C-Y-W135 (D Conj) Vaccine but declined to receive a booster in high school prior to college, with no reported adverse event (Booster dose missed).  It was reported that patient's oncologist is recommending revaccinations due to her immunity being "wiped out" due to cancer treatments.  Action taken with Meningococcal Vaccine (Menactra) was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
60 Sec seizure, afebrile in day after shots, Family history of seizure disorder.
Bilateral Tinnitus - constant hissing sound that got louder after vaccine 3. Was told by medical professional tinnitus is not curable and a permanent medical condition.
a patient received only the liquid portion of Menveo; a patient received only the liquid portion of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA955A, expiry date 31-JUL-2024) for prophylaxis.   On 29-JUN-2023, the patient received the 1st dose of Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient received only the liquid portion of Menveo) and inappropriate dose of vaccine administered (Verbatim: a patient received only the liquid portion of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter reported that a patient received only the liquid portion of Menveo and wished to receive information about how to proceed.  The information about the event, vaccine and patient was given. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  The reporter reported that a patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
eye and muscle twitching; muscle twitching in her arms and behind her legs/twitching behind her calf and thigh. Every once in a while she feels a twitch twitch kind of thing; nosebleeds; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: Jun2021) via unspecified route on an unknown date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine. The patient experienced symptoms like eye and muscle twitching with nosebleeds. She specified the nosebleed occurred twice, while her eye and muscle twitching are still happening. She added the muscle twitching was in her arms and behind her legs. It was reported that side effects were a couple of times she had a nose bleed and then she has been feeling like a little eye twitching and the same twitching behind her calf and thigh. Every once in a while she feels a twitch twitch kind of thing. She asked if she should receive the second dose of the vaccine given her reaction to the first. She specified her doctor recommended her to call Pfizer. The outcome of the events eye and muscle twitching and muscle twitching in her arms and behind her legs was not resolved and outcome of the event nosebleeds was unknown.  No follow up attempts are possible. No further information was expected.
Swollen lymph node under arm that was injected for 2 days; headache; body ache; tiredness; This is a spontaneous report from a non-contactable pharmacist (patient).   A 24-years-old female patient received the secondo dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# El0140 on left arm on 18Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation . First dose details reported as follows: product=COVID 19, brand=Pfizer, lot number=El0140, administration date=28Dec2020, administration time=04:00 PM, vaccine location=Left arm, dose number=1}] Medical history included Pineapple  allergy . Concomitant therapy none.There were no concomitant medications.  The patient started to develop at 7:00 on 19Jan2021 Swollen lymph node under arm that was injected for 2 days, headache, body ache, tiredness that lasted for 3 days.No treatments recevied. Outcome of the events was reported as recovered in Jan2021.  No follow-up attempts are possible; No further information expected .