chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a pediatric patient who was vaccinated subcutaneously with the second 0.5ml dose of VARIVAX (Oka/Merck) over the last six months. The patient developed injection site reaction after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. Follow-up information was received from a registered nurse (R.N.) in the physician's office which reported a 12 month old patient with acoliosis, allergy to "alcohol prep pad", no illness at time of vaccination and no adverse event following prior vaccination who on 05-Feb-1999 was received the first dose of VARIVAX (Oka/Merck) and had shingles after receiving the first dose at 12 months. On 24-Feb-2009 at 4:15 pm the now 11 year old patient was vaccinated SC with the second dose of VARIVAX (Oka/Merck) in the left arm (lot# 662380/1756X). Concomitant therapy at the same time included the first dose of MENACTRA (Lot# U2827CA) given IM into the right thigh and the first dose of BOOSTRIX (lot# AC52BC24DB) given IM into the left thigh. On 25-Feb-2009 in the morning the patient called to the office stating that she experienced swelling with red area at the site of injection on the left arm. The body temperature was 99. On 26-Feb-2009 the patient reported that she still experienced red, hot and itchy with swelling and very tender to touch. The patient's mom was asked to mark borders. On 27-Feb-2009 in the morning the patient's mom called to reported that it was still hot, red (not as/ red) and larger red area on one border, smaller at top border. Office visit was recommended but it was not specified if the patient was seen in the office or not. This is one of several reports received from the same source. Additional information is not expected.
Patient presented to ER at the Medical Center with nausea vomiting and diarrhea and headache with altered mental status. She had low grade fever with highest being 101.7 F. She was then life flighted to hospital for more specialized care on 6/8/2017 around 4am. She had completed her sports physical in our office that day. Her urine was within normal limits and EKG was within normal limits. Upon admission to ER she had test ran in which urinalysis was abnormal. CT was WNL, monospot was WNL.
Nausea, bloating, gas, and pain at the injection site. Nausea set in 3 hours after injection and lasted about 36 hours. Bloating and gas continue day 3. Pain set in 10 hours after injection and lasted 24 hours. No medical attention needed, tea, soup, fluids, moving the arm, and rest helped.
Rash; First dose of Shingrix on 07-May-2018; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, the patient experienced rash and incomplete course of vaccination. On an unknown date, the outcome of the rash and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed rash. The reporter asked could receive second dose and how to continue with the schedule as was going to be late for second dose, which led to incomplete course of vaccination. The reporter consented to follow up. The reporter did not had further vaccine details. No further information provided.
Information has been received from an approximately 56 year old male consumer with type 2 diabetes mellitus and no drug reaction or allergy who in 2006 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 and there was no adverse reaction. In 2007 the patient was vaccinated with another 0.5 ml dose of PNEUMOVAX 23 (lot# 658449/0989U). Concomitant therapy included metformin, GLUCOTROL and GLUCOPHAGE. The patient indicated that in 2007 he developed swelling on the injection site "a couple of days after the shot was given and the swelling goes away but come back every now and then." The patient also reported that he was still experiencing some pain on his arm and it won't go away. The patient sought medical attention via visit physician. No laboratory diagnostics studies were performed. At the time of the report, the patient did not recover. Additional information has been requested.
After initial vaccine, patient while in observation began to become lightheaded, nausea, dizzy and head became fuzzy. Patient increased anxiety during the event. Slight "tingling entire body". No difficulty swallowing, no rash, no hives, lungs clear  140/76, 90, 99% room air (Initial) 102/62, 87, 98% room air (Secondary)  No treatment other than assessment,  patient insists feelings are from vaccination.
vision loss; Shingles; Information has been received from a lawyer regarding a case in litigation and refers to a currently 77-year-old patient (pt) of unknown gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  On or about 31-OCT-2011, the pt was vaccinated, at a local pharmacy, with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dose, route of administration, anatomical location, lot # and expiration date were not reported).  Subsequently, on an unknown date, pt was treated by local providers for the following injuries resulting from pt's zoster vaccine live (ZOSTAVAX) use: shingles and vision loss (blindness). At reporting time, the outcome of events was unknown.  Upon internal review, blindness was considered a medically significant event.
Moderna COVID-19 vaccine EUA on 04/21/2021 and tested positive via nasal swab PCR on 05/29/2021.
Itchy red rash, <20% TBSA occurring one hour after recieving the vaccine. Treatment: IM SoluMedrol, oral Benadryl and Pepcid.
Feels like a really bad hangover; Still don't feel good; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover). At the time of the report, FEELING ABNORMAL (Still don't feel good) and HANGOVER (Feels like a really bad hangover) outcome was unknown.            No concomitant medication was reported , No treatment medication was reported . Action taken with mRNA-1273 in response to the event was not applicable.
This is a spontaneous report from a contactable nurse (patient's wife) via Medical Information Team. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 04Feb2021 13:15 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 14Jan2021 at 13:15 for COVID-19 immunization. The patient experienced soreness in his neck and shoulders on an unspecified date and after the 11th day after the vaccine, the patient experienced double vision in one eye on 15Feb2021. On 18Feb2021, the patient recovered from double vision in one eye while outcome of soreness in his neck and shoulders was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient was noted to have papular, vesicular lesions and scabs on face, scalp and trunk. Patient was diagnosed with chicken pox vaccine failure.
mom states pt had 105 fever & very fussy;MD @ ER that noc found OM;pt had been checked & no OM earlier that day;had f/u appt w/own MD a few days later;MD felt rxn was combination of vax & OM;
No adverse effects reported; VARlVAX which was administered with expired DILUENT MRK JNJ; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.      On 07-JAN-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) with lot # N023961 with expiration date on 01-SEP-2019 that was diluted with an expired sterile diluent(MERCK STERILE DILUENT) with lot # L028663 that expired on 29-MAR-2018 for prophylaxis (dose and route of administration were not reported). On 28-FEB-2019, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) with the same aforementioned lot number for prophylaxis with an expired sterile diluent(MERCK STERILE DILUENT) with lot# L028663 that expired on 29-MAR-2018. However, no adverse effects were reported.
TIRED EASIER AS LONG TERM SIDE EFFECT; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-AUG-2021, the patient experienced tired easier as long term side effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired easier as long term side effect. This report was non-serious. This case, from the same reporter is linked to 20211259114.
Shingles; PAIN IN THE HIP AREA; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2019, 32 days after receiving Shingrix, the patient experienced shingles and pain in hip. On an unknown date, the outcome of the shingles and pain in hip were unknown.   It was unknown if the reporter considered the shingles and pain in hip to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's sister. The patient experienced pain in the hip area and developed what appeared to be a shingles outbreak on her hip area. The caller reported that the patient would be going to see physician on the reporting date to be evaluated. The reason the reporter called was her sister received the Shingrix vaccine 31 days ago from the reporting date and on the reporting date she developed shingles. The patient seemed too much of a coincidence.
Initial unsolicited report received from a pharmacist on 10 July 2015. A female patient (age not reported), whose concomitant medication was not reported, had received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Adacel) (batch number: U4875AA, expiration date, dose and dose number were not reported) intramuscularly in upper quadrant of Gluteal site on 25 June 2015 or 01 July 2015. Since Adacel was administered in the gluteal region, its an inappropriate site of vaccine administration for Adacel. The patient also received a dose of HEPATITIS A VACCINE (Hepatitis A) (batch number, expiration date, dose, dose number, route and site of administration were not reported) and also a dose of HEPATITIS B VACCINE (Hepatitis B) (batch number, expiration date, dose, dose number, route and site of administration were not reported) in arm on 25 June 2015 or 01 July 2015. The patient's medical history was reported as allergy to azithromycin and sulfa. On an unspecified date post-vaccination, the patient experienced sciatica pain. The patient required ER/doctor visit as the patient was seeing a chiropractor for the event. Laboratory investigation and corrective treatments were not reported. As of 10 July 2015, the patient had not recovered from the event. Follow-up information received from pharmacist on 18 August 2015. Patient's age was reported as 72 years. Patient was vaccinated on 25 June 2015 with Adacel (expiry date: 02 May 2016), Hepatitis A vaccine (manufacturer: Merck, batch number-L005558) and Hepatitis B vaccine (manufacturer: GSK, batch number- 3FZ74 and expiry date: 29 August 2015. The patient recovered from the event on an unspecified date. List of documents held by sender: none.
5 patients received a full vial (3.0 ml reconstituted dose) of yellow fever vaccine by mistake.  There is currently no symptomatic complaints.  This patient was identified as one of the possible recipients.
Moderna COVID-19 Vaccine EUA  Moderna Covid19 vaccine (2nd dose) was administered Monday Feb 22. 1 day later I experienced the expected side effects - muscle aches, chills.  2 days after the 2nd dose of the vaccine I noticed a red rash all over upper body and back, from waist to neck.
Mom brought child on 9/24/02 for four year old shots, which was DTaP, IPV and MMR. DTaP given in R deltoid with a 1" needle/syringe. On 9/25/02 client brought in by mom to show us arm where DTaP given R arm red and warm from deltoid down to elbow. Child is not running fever or fretting. Told mom use cold compresses and Benadryl po. If it does not get better return to clinic very large area of red and warm to touch.
Pt recvd 3 doses of Hep B;  titers drawn & neg for HBSAG antibodies; determined to be a nonresponder or that titers dec rapidly;
I have all of the usual side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 71-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st April 2020, the patient received the 2nd dose of Shingles vaccine. In April 2020, less than a week after receiving Shingles vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingles vaccine.  Additional details were reported as follows:  The patient got second shingles shot the day before reporting.  The patient had all of the usual side effects.  The patient asked how long should the patient expect the side effects to last.
Anaphylaxis; hypersensitivity reactions; Injection site reactions; headache; feeling tired; This is a spontaneous case received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient experienced small rash after the first dose didn't itch, headache and feeling tired on an unspecified date. She treated her symptoms by taking 2 Tylenol. Spoke from fact sheet Adverse Reactions in Post Authorization Experience: Severe allergic reactions including anaphylaxis and other hypersensitivity reactions (e.g rash pruritus urticaria angioedema) had been reported following administration of the Pfizer BioNTech COVID 19 Vaccine during mass vaccination outside of clinical trials. Injection site reactions duration was 2.5 days. The outcome of the events headache, fatigue was recovered on an unspecified date, while other events were unknown.  Information on the lot/batch number has been requested.
In early April 2023 I had lots of postnasal drip, coughing, mucus and fatigue.  My nasal passages were swollen.  My ears were bothering me as well because they felt full of fluid.  I also had a sore throat.  These symptoms lasted for about 1 month.  I tested negative for COVID-19.  I went to the doctor on April 19, 2023, and was diagnosed with sinusitis.  I was given antibiotics.
Had a reaction each time; Got really sick; Bad headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA. At the time of the report, ADVERSE REACTION, ILLNESS, HEADACHE, and NAUSEA outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-370042, MOD-2021-370027 (Patient Link).
This spontaneous report as received from a healthcare worker, practice manager refers to a unknown patients of unknown age and gender. On an unknown date the patients were vaccinated with MMR II (dose and route not provided). The health care worker reported, the storage compartments that contained MMR II were not monitored at all from 03-MAY-2014 until the report time. The MMR II was stored in the same compartment as the VARIVAX (MARRS # 1406USA007318) and ZOSTAVAX (MARRS # 1406USA007321). Doses of the vaccines that were exposed to unknown temperatures were administered to unspecified patients. The practice manager will provide the names of the patients who received doses of the un-monitored vaccines in during the period of time from 03-MAY-2014 until the present. She states that her practice has not been informed of any adverse experiences. No additional information was provided. This is one of several reports from same source. Additional information has been requested.
No reaction. Was given 1 week early. It should have been given 4 weeks after the first shot, but was given 3 weeks after the first shot. Patient will need another shot .
t103.2 R PM onset 4JAN93 mom says has red splotches on arms & shoulders since onst of fever did go away when temp dec; fussy;
Soreness on the left arm; left hand felt cold; barely use left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025821A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-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 PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm). At the time of the report, PAIN IN EXTREMITY (Soreness on the left arm), PERIPHERAL COLDNESS (left hand felt cold) and LIMB DISCOMFORT (barely use left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Fatigue Vaccination site pain Headache Paraesthesia  Fever ? 38°C Arthralgia  Pain  Chills Oropharyngeal pain Hyperhidrosis  Abdominal pain Asthenia  Myalgia  Adenopathy/lymphadenopathy
Not exactly sure the onset but in retrospect the adverse event "symptoms" occurred during the two or so weeks following the vaccination date and on 6/17/12 patient was diagnosed with Type 1 Diabetes.
I started itching all over my face and back. It was very annoying. I visited the ER to get steroid shot per the pharmacist at pharmacy. It lasted for a couple of hours and stopped almost immediately after the steroid shot.
got the shingles vaccine, came up on my temple/ Suspected vaccination failure; came up on temple where I had chicken pocks; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included fibromyalgia.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had fibro and got the shingles vaccine, shingles came up on temple where he/she had chicken pox. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Extreme soreness, elliptical red and swollen rash around injection site approx. 6 inches.
On April 7 I felt itchy arms which I thought was related to a soap that I was using at a hotel. That day around 3 PM I felt exhausted and had to lie down. The next morning I woke up With a puffy face. The next morning I woke up feeling as if my teeth had punctured my inner cheeks around my job. Friday, 9 April I was still puffy and it was more pronounced on the left side of my face. From there it gradually became more swollen over the next few days before I went to urgent care.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender who on an unknown date may had received a dose of GARDASIL, in the gluteal muscle. The patient was not experiencing any known symptoms. Additional information has been requested.
pt deveolped some mild dizziness after receiving the janseen vaccine and standing   he was placed in a trendelenberg position initial BP was 158/70 he denies associated allergies symtoms    symptoms resolved in 15 to 20 mins.  patient was observed for 30 mins and then "felt normal"    and walked around the office without difficulty   before being discharged home, pt signed up for V-Safe during observation     discharge pt was instructed to follow up with his PCP about his BP  when he returns to another country    mild vertigo reaction after covid injection  follow through with V Safe
Patient reports 8 hours after vaccine administration she developed the following symptoms: tightness in chest, weakness, fast heart beat, dizziness, headache, chills, very sore arm, unable to lift up arm, redness around injection site the size of a softball.  24 hours after vaccine administration patient reports vomiting and diarrhea, with continuation of the previous symptoms as well.  All of these symptoms continued until 48 hours after vaccine administration.
Patient called into triage line reporting soreness on her right neck, jaw, collarbone and shoulder, and those areas feel warm and are slightly inflamed.  Immunization given R deltoid. Happened 2 days after injection.