chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 13-MAR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe.
About an hour after receiving the Moderna shot, I became extremely dizzy. It felt like cold water surged through my body from my fingertips to the tips of my toes. It lasted about one minute.   I thought someone should know.
The patient called the pharmacy today reporting that she has muscle aches and headache following her Janssen vaccine on 4/8/21.  She states she developed numbness in the left cheek starting on 4/9/21.  For reference she says the vaccine was given in the left arm.  The numbness comes and goes.  I encouraged her to register for VSAFE and report her symptoms and to notify us if anything else develops.
Abnormal menstrual cycle with heavy bleeding for weeks; Shortness of breath and arrhythmic heart beats. Pain in left chest area sometimes
Head fuzziness, extreme headache, nausea, left arm went numb and lost feeling in left hand
COVID 19 Treatment; COVID 19 Treatment; received Moderna vaccine as booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Lot number: EN6204), in left arm and on 31Mar2021 as dose 2, single (Lot number: ER8737) at the age of 70 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Oct2021 as dose 3 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 07Sep2022 as dose 4 (booster), single (Lot number: 157143C), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 13Oct2021, outcome "unknown", described as "received Moderna vaccine as booster dose"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19, patient was treated with PAXLOVID from 08Feb2023 to 12Feb2023.
I get a bad taste in my mouth when i eat certain foods. It started the first time i ate just after the shot. The taste is not in my mouth all the time, just when i eat certain foods. Usually it is red meat that causes the taste. The taste is hard to describe. It is bad but does not make me sick to my stomach. It has been two weeks since the shot and the symptom os still the same.
This spontaneous case reported by a consumer, describes the occurrence of nasal congestion (stuffy nose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included seasonal allergy. Concomitant products included desmopressin for an unknown indication. On Mar 17, 2021, patient received second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; dosage 1 dosage form. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 17, 2021, patient experienced nasal congestion (stuffy nose). The patient was treated with Flonase (fluticasone propionate) for nasal stuffiness, at an unspecified dose and frequency. At the time of the report, nasal congestion (stuffy nose) outcome: unknown. Patient did not get a stuffy nose from the use of Moderna. However, as per initial document, patient had it before the 2nd dose which confirms that patient had it after the 1st dose. Action taken with the product mRNA-1273 not applicable. Most recent follow-up information incorporated above includes: On May 7, 2021: medical history and clinical information updated.
Delayed Injection site reaction. It?s become swollen, red and hot and it?s extremely big and growing. I also came down with flu like symptoms a week after and my breastfed baby is having them as well.
I am 34 weeks pregnant. My estimated delivery is 9/15/2021. I received the Pfizer vaccine on 8/9/2021 around 1:10pm at pharmacy. I have had absolutely no issues this pregnancy and uncomplicated up until now.  The evening of 8/9/2021 only hours after vaccine I started getting tenderness and tingling right above my buttock. I do have a history of HSV-1. I just thought the vaccine may have triggered prodrome symptoms. In the middle of the night on 8/9/21 and into 8/10/21 the buttock sensitivity now spread into both upper thighs and up wards to the middle of my spine.  In the middle of the night on 8/10/21 and now into 8/11/21 a whole different nerve sensation began. I now have prickling sensations that appear and go away in all different areas of my body from the face down to my feet.  This is no coincidence. Everything started right after the vaccine.  I went to my OB today to check my fetus. Everything is ok with the baby. If the nerve sensations continue to progress I was advised by my physician at to go to labor and delivery and have a Neurology consult scheduled. They definitely believe I am having a reaction from the vaccine. Gabapentin was even suggested. I will not take that at this time.  I will most likely not get the second round of Pfizer.
Initial report received from a healthcare professional on 23 July 2013. A female patient whose age, medical history and concomitant medications were not reported, had received a dose of MENACTRA vaccine (lot number: U4611AA, dose in series, route and site of administration were not reported) on an unspecified date. On an unspecified date, post vaccination the patient experienced fever and sore neck. The patient had no "ED", vomiting, nausea or confusion. Laboratory investigations and corrective medication were not reported. At the time of this report, the outcome of events was not reported. Documents held by sender: None.
headache; ran down and tired; left arm on her injection site felt like it was bruised; nauseated; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm, on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included being immunocompromised, neck surgery (pretty intensive and took a long time to heal) on May2020, stage 1 melanoma cancer and was removed on 03Dec2020, chronic pains and arthritis. The patient's concomitant medications were not reported. The patient's historical vaccine included flu shot. On Mar2021, the patient experienced headache; ran down and tired, left arm on her injection site felt like it was bruised (like somebody punched it) and nauseated. It was reported that the patient mentioned that this felt like the flu shot but worse. The patient was very wary of getting the 2nd dose because she might experience these side effects again. The patient heard that the 2nd dose might give worse side effects and would like to clarify that. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021362558 same reporter and drug, different patient and event
immediate arm pain after injection was done, sat down and took tylenol and exercised arm, after 15 min went to car and put ice on arm and had a difficult time driving due to the intense pain in arm.  Came home had diarrhea, intense burning pain in left side of chest, upper left arm and neck,jaw and back of shoulder pain.  iced again no relief, pain and burning kept increasing, kept exercising my arm, felt tired but couldn't sleep due to the tremendous pain and burning.  4 hrs later my palms of hands turned white then blueish and went numb for about 10 minutes. kept icing and exercising my  arm until I went to bed and took a tylenol pm and  ibuprofen. Slept but continued to have burning and arm pain through the night.  Next  day continued with arm pain and burning but the intensity came down a bit.  Wednesday still burning in neck and jaw . Thursday have knee pain on right knee along with burning pain from groin to the instep in right leg for half the day.  More diarrhea and continued burning in neck and shoulder left side.
got the shot and got shingles/Suspected vaccination failure; shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 The case was received from the patient via interactive digital media.  The patient got the shot and got shingles (at the time of reporting). They would not go away. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
03/21/2022 - I started feeling pain in my leg, shoulder and arms. My legs hurt really bad when I stand up. I noticed a large knot in the muscle part of my leg which turned into a bruise.
First I got very drowsy  and then I got body aches and a high fever where I sweat so much my bed sheets got soaked with sweat. I didn't take my temperature. Another thing that happened was the tip of my right middle finger went numb for a few hours. I noticed this around 7pm the day I got the shot. This numbness has never happened to me before. My fever lasted until the morning after I got my shot. Fatigue lasted into the second day after the shot.
Terrible arthritis flare up in knees and back.; having bad arthritic pain; This is a spontaneous report from a contactable consumer (reported for himself). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on an unspecified date in Mar2021 (seven months prior at the time of report; also reported on "08Feb2021"; pending clarification) (at the age of 71-year-old) (Lot Number: En6201) as dose 2, single for COVID-19 immunization. Medical history included diabetes. No known allergies. The patient's concomitant medications were not reported. The patient previously administered BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 08Feb2021 at 03:30 PM (at the age of 71-year-old) (Lot Number: EI9265) as dose 1, single for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient no COVID prior to vaccination and was tested for COVID post vaccination with molecular nasal swab on 21Sep2021: unknown results. On 15Mar2021 at 12:00 PM, the patient experienced terrible arthritis flare up in knees and back. Still not able to walk or stand more than 5 minutes. Seven months after the second shot (Mar2021) and still having bad arthritic pain. These events resulted in Doctor or other healthcare professional office/clinic visit and disability or permanent damage. Treatment was received with prednisone, gabapentin, and spinal physical therapy. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Half dollar sized, oblong red, raised slightly, non tender, area on back of left upper arm. Onset Thursday 10/2/15  evening at home. No treatment needed at this time.
chest tightness, wheezing, sob, lightheaded. Evaluated by EMS-Refusal to transport.
received Boostrix inadvertently; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter was a medical assistant. The patient received a dose of the Boostrix vaccine inadvertently, which led to wrong vaccine administered. The reporter did not consent to follow-up.
locally at the injection site of his arm: redness; locally at the injection site of his arm / hot; locally at the injection site of his arm / pain/hurt/ locally at the injection site of his arm: pounding; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a male patient who received Men B NVS (Bexsero) (batch number ABX657AA, expiry date 30th April 2019) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st November 2018, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site pain were recovered/resolved.   The reporter considered the injection site erythema, injection site warmth and injection site pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter was the patient's mother. The patient received 1st dose of Bexsero in an unknown arm.  The patient experienced redness, hot, pounding, pain or hurt locally at the injection site of his arm and these events resolved after 2 days. The reporter consented to follow up and provided her email address but not a fax number. For tolerance to the 2nd dose of Bexsero, refer linked case US2021AMR070410, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR070410:Same reporter
8/21/07 AML Tdap given. PM - left arm and body aches. 8/22/07 -8/27/07 - Body aches and left arm sore. 8/24/07 - 1 PM Wheezing and chest tightness (but was around cats). 8/24/07 PM increased body aches, felt "hot", increased arm soreness, some redness. 8/25/07 AM increased arm redness - below injection site to elbow - splotches. 8/26/07 PM to ER dept.; given Keflex 500 mg 4x/day x 7 days. 8/28/07 - To PCP - given SoluMedrol injection. Improving since arm redness resolving.
After 5 minutes of injection, patient felt dizzy and fell while sitting. Patient fell face down hitting his forehead that is bruised and started bleeding from his nose. Patient was cold and clammy upon touch of the hand. Patient stated that he had not eaten anything all day except for a banana. When asked what time the patient woke up the patient said "several hours before coming".
Information has been received from a licensed practical nurse concerning a 19 year old female who was vaccinated with 0.5 ml of Gardasil (Lot #658558/1061U) intramuscularly in the deltoid.  The nurse reported that the patient had extreme pain and numbness in her arm after she was given Gardasil.  The nurse was unsure which Gardasil dose this occurred with.  As of 10-JAN-2008 the patient had not recovered.  No other information was available from the nurse.  Additional information has been requested.
Noticeable hives all over his face.  Injection site red and swollen.  The next day (5/25/15) injection site swelling increased and hives still present.  5/26/15-  Very sore, red, swollen injection site.  Hives still present on his face.  Benadryl administered orally.
feeling soreness on the injection site; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid 19 Vaccine, solution for injection), via an unspecified route of administration on 25Feb2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient feeling soreness on the injection site. She wants to know if she can take tylenol or apply heat on the injection site. The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
rapid test that was positive for COVID-19; having temperature/temperature of 99.9°F; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9°F) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced PYREXIA (having temperature/temperature of 99.9°F). On 11-Aug-2021, the patient experienced COVID-19 (rapid test that was positive for COVID-19). At the time of the report, COVID-19 (rapid test that was positive for COVID-19) and PYREXIA (having temperature/temperature of 99.9°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive. On 13-Aug-2021, Body temperature: 99.9 (High) 99.9 Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   It was reported that patient had a polymer chain reaction (PCR) test and result pending at the time of this report.  No treatment information was provided.
I started having headaches on the right side of my head consistently every single day. It's a throbbing, dull ache and only occurs in the same spot (right above right ear). Shortly after, I started getting hives and a rash. I consistently took Benadryl and it didn't help. I went to my PCP for the head pain and rash and was prescribed Gabapentin. The Gabapentin did nothing for the pain. The rash still continued as well. I started taking Loratadine and that finally helped the rash. Weeks went by and the head pain was so bad that I decided to go to the ER for a CT Scan to make sure it wasn't anything bad. They didn't find anything after the scan but the head pain has continued relentlessly. It's making it very difficult to concentrate or just function in day-to-day activities. It's now been 3 months since my COVID shot and I feel like this has to be the cause of all my issues.
This spontaneous report was received from a physician referring to a multiple patients of unknown age and gender. These patients' concomitant medication, pertinent medical history and drug reactions were not reported. On unspecified dates between 31-MAY-2017 and 21-JUN-2017, these patients were administered improperly stored GARDASIL 9 (lot# M024261 with expiration date 30-JUL-2018, lot# M035486 with expiration date 05-JUN-2019, dose and route not reported) for prophylaxis. The vaccine was exposed to temperature excursion of 34 Fahrenheit (F) for 90 minutes and 49 Fahrenheit (F) for 30 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010784: US-009507513-1709USA005364.
19DEC95 PM pt c/o tightness in chest, body aches, c/o burning up but no elevated temp;20DEC95 c/o chilling saw PMD who prescribed Pred x 3 days;pt pale;21DEC95 adm to hosp-02 level very low;dx asthma, viral pneumonia;24DEC95 d/c from hosp
19 year old male presented for smallpox vaccination on 9SEP2015, also issued medication to treat current case of tinea pedis. Patient did not follow recommended follow up instructions for 7 days post vaccination and presented on day 9. Satellite lesions noted, as well as increased severity of tinea pedis, along with improper vaccination site care. The following day Patient presented to the Emergency Room for possible generalized vaccinia (10 days post vaccination), patient was febrile (104 degree oral temp), tachycardic, and had a transient blood pressure of 110/70. Treated with fluids and anti-inflammatories at ER. No labs drawn at this time due to vital signs. Patient followed up next day (day 11) to rule out meningitis and encephalitis. Asymptomatic at that time, however, later that night patient presented again to ER with 102.8 degree temperature, tachycardia and was treated for possible streptococcal pharyngitis. Rapidstrep, CBC and monospot labs taken, and later results were positive for infectious mononucleosis, which could have contributed to systemic spread by suppressing the immune system. The next day (day 12, 21SEP2015) patient presented with multiple smallpox lesions on the feet, one on the face, four on the lower back, and one on the right leg along with the same number of satellite lesions as noted on day 9. Patient referred to Dermatology same day, diagnosed with generalized vaccinia due to systemic spread and not accidental autoinoculation. Normal vital signs noted and recommended isolation precautions x14 days. Patient currently is checked twice a day to monitor for vital signs and possible development of new lesions.