chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had my booster shot on the afternoon of December 7th, and when I woke up on December 8th, I felt horrible. I had chills, felt feverish (my skin felt hot), had body aches, and was extremely fatigued. I checked my temperature several times throughout the day, and the highest temperature I had was 99.1 (my normal body temperature is around 97.8-98.0). I noticed that the soles of my feet, the palms of my hands, and my groin area were the areas of my body that ached the most. By the morning of December 9th, I felt better, but was still fatigued and the soles of my feet still felt achy. On the morning of December 10th, I noticed that the ache in the soles of my feet was more like a tingly feeling (like pins and needles when your foot falls asleep and wakes back up). Throughout the day on December 10th, I had weird zaps of nerve pain in all different parts of my body. The zaps would last about 5-10 seconds, and some were minor (felt more like itching), while some were more painful (about a 7-8 on the pain scale). I called my doctor's office to see if I could make an appointment, but they could not see me until Monday, December 13th. I decided that if it got worse over the weekend, that I would go to urgent care. Luckily, it did not get worse, but the random nerve pain lasted through the weekend and was still happening on Monday when I met with my doctor. By Monday, it had changed to more of an itchy feeling, but I still had occasional nerve pain zaps that were around 5 on the pain scale. During my appointment, my doctor said that it was possible that I was having a reaction to the vaccine, but she ordered some blood tests to rule out other possible sources of neuropathy. She put in an order for a lipid panel, and to check my Vitamin B12 levels, and thyroid hormone levels. I had my blood work done on Thursday, December 16th (as that was the earliest I could go in due to work), and all results were normal. Since then, the nerve pain/itchy zaps have continued to improve. However, I do sometimes still get nerve pain/itchiness.
Pt developed red patches on bilateral forearms to elbow, reported a slight itch which resolved within about 5 minutes with a cold pack. Pt reported that her arms were itchy earlier in the day but patches were not present to arm at time of injection. Pt assessed by Nurse Practitioner in office who advised additional 15 minute monitoring in office . Pt reported itch had resolved. Nurse Practitioner in patient room for reassessment who had ok'd pt to leave office and recommended Benadryl as needed.
Patient had witnessed seizure lasting 2.5 minutes one day after receiving SHINGRIX vaccine at local pharmacy.
This case was reported by a nurse via call center representative and described the occurrence of itchy rash in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 2nd dose of SHINGRIX .5 ml. On 26th September 2018, 4 hrs after receiving SHINGRIX, the patient experienced itchy rash, blotchy rash and pustular rash. The patient was treated with Cortisone Cream. On an unknown date, the outcome of the itchy rash, blotchy rash and pustular rash were not recovered/not resolved. It was unknown if the reporter considered the itchy rash, blotchy rash and pustular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was a nurse who was also the patient. The patient had the vaccine on left arm and reported that about 4 hours after the dose she developed an itchy rash that had spread. The patient reported that rash was on her back, mid-section, and left shoulder. The patient stated that rash was itchy and was in blotches and had a center and pustule. The patient had been seen by dermatologist and was prescribed cortisone cream. The dermatologist had taken culture from pustules and did not have results back still at the time of reporting. The contact details of the dermatologist was provided.
This spontaneous report as received from a nurse refers to an unspecified patient of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-SEP-2015, the patient was vaccinated with the first dose of GARDASIL series injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. The patient was in the office at the day of the report (i.e. on 10-NOV-2015) in order to receive the 2nd dose in the series as an unspecified dose of GARDASIL 9 injection (strength, dose, route and lot number or batch number unspecified). No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. Additional information has been requested.
Mom reported on 12/8/09 that after patient received her first dose of the h1N1 vaccine on 11/02/2009, 4 hours after she was given the shot, she developed a fever of 102*F  Mom called her PCP who instructed her to alternate giving her Tylenol and Motrin. Then about 4 days later, mom took patient to Med Express where she was diagnosed with sinusitis and was given a rx for an antibiotic.
A non-serious spontaneous report of 67 year old got a dose of H1N1 LAIV was received from a registered pharmacist/healthcare professional concerning a 67-year-old female. On 17-Dec-2009 the patient received a dose of H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved.
Urticaria; instructed to use DPH & Pediapred; Seen in ER;
Headache, Myalgia, Fever, Sire pain, swelling, redness
The medication leaked out of the injection site and running down her arm, while the needle was still; The medication leaked out of the injection site and running down her arm, while the needle was still; The medication leaked out of the injection site and running down her arm, while the needle was still; This spontaneous case  was received on 29-Sep-2020 from a pharmacist via agency (reference number: SEQW20-02562) and concerned a 70-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On 29-Sep-2020, while the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose and anatomical location: not reported) for influenza prophylaxis, the medication leaked out of the injection site (explicitly coded as 'Incomplete dose administered'). The medication was running down the patient's arm while the needle was still in the injection site (explicitly coded as 'Accidental exposure to product'). The batch number reported was 279810, expiry date: 30-Jun-2021. According to the health professional, a good amount of vaccine was expelled out of the syringe.   At the time of initial reporting on 29-Sep-2020, the outcome of the event 'Vaccination site extravasation' was not reported. No side effects were reported by the patient.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company comment: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, the medication leaked out of the injection site and was running down her arm, while the needle was still in the injection site. Vaccination site extravasation is assessed as not related to the vaccine substance. Incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.; Sender's Comments: A patient was administered incomplete dose of Fluad Quadrivalent. Reportedly, the medication leaked out of the injection site and was running down her arm, while the needle was still in the injection site. Vaccination site extravasation is assessed as not related to the vaccine substance. Incorrect dose administered and accidental exposure to product are assessed as not related, per company's conventions.
The patient was fine directly after administration and for the first few minutes. He started feeling lightheaded and then experienced a syncopal episode. Patients eyes were open wide and was not responding. Checked for pulse which was present. Called EMS. He start responding after 2-3 minutes and was unaware of what happened. A few minutes later he started feeling better. EMS checked patient and he was fine. He was not taken to the hospital.
Light headed after couple of hours, numbing of R Arm, for 1st day. Temp 101 degrees, chills, headache, blood in urine
slight discomfort at the injection site; second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-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 VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose). At the time of the report, VACCINATION SITE DISCOMFORT (slight discomfort at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported     Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up document received on 23-04-2021 contains No New Information.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 years old adolescent patient and unknown gender. On 08-AUG-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot J009788, expiration date 17-MAR-2016)(dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Info has been received from a registered pharmacist concerning a 20 year old female with no known drug allergies or past medical history who was vaccinated with a 2nd dose of Hep-B. There was no concomitant medication. The pharmacist reported that the pt received 3 doses of Hep-B vaccine but the 1st dose was not recorded. The pharmacist further reported that the 3rd dose was given 6 months following the prior dose. Subsequently, in 2002, the pt developed a fever for 1 day and muscle aches on another day which had both resolved. In approx. 11/02, a lab test revealed the pt had elevated liver enzymes. The outcome was not reported. The pt sough unspecified medical attention. Additional info has been requested.
This non-valid spontaneous report was received from a registered nurse and refers to an unspecified number of patients. No information regarding the patients' medical histories or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # N013989 with expiration date on 30-JAN-2019. The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 15 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.
12:51pm post vaccination vasovagal episode w/brief syncope; reports feeling shaky and seeing spots, appears flushed, skin clammy. Medical monitoring w/ rest, po hydration/ juice; vital assessment: BP 98/62 P60  O2 sat 98% RA During monitoring reports symptom resolve w/no additional complaints; released from facililty w/ husband
I had the first dose of the SHINGRIX vaccine at a local pharmacy on 2/21/19. On 2/24/19, I began noticing a rash under my arms, armpits, abdomen, groin area, and legs. It came on quickly and became quite uncomfortable. My hands became swollen, red, and burned. I went to the doctor on 2/25/19. I am now taking Prednisone and Famotidine twice a day, as well as BENADRYL as needed.
Shingles rash today, vaccination yesterday; Shingles rash today, vaccination yesterday; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th October 2022, the patient received Shingles vaccine. On 28th October 2022, 1 days after receiving Shingles vaccine, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022. Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had got the shingles rash on the reporting day and after receiving the vaccine the day before reporting. Additional supportive information: Follow-up would not possible as no contact details were available.
Patient presented to primary care clinic complaining that right upper arm was red and tender. No shortness of breath or chest pain. Diphenhydramine 25 mg once.
AFTERTASTE WITH ALL FOODS; BODYACHE THENIGHT OF VACCINATION; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in right arm on 18Mar2021 at 08:30 as a single dose for COVID-19 immunisation. The patient did not have any medical history. Any allergies to medications, food, or other products were not known. Concomitant medications included colagen (MANUFACTURER UNKNOWN) and unspecified supplements (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 25Feb2021 at 16:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021, the night of vaccination, the patient experienced body ache. On 22Mar2021, three days after 2nd vaccination, the patient experienced aftertaste with all foods. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event aftertaste and body ache was unknown at the time of report.   No follow-up attempts are needed. No further information is expected.
about 5 days after receiving vaccine developed local 4cm x 2cm area of redness and itching
pt recv vax;child slumped forward on chair,pale,LOC;appeared stiff & jerky,eyes closed,blue around lips;child had urinated in paints; took approx 60 sec before responding to name;irregular;MD felt pt had a fright rxn;vasovagal rxn;sz
I got the covid 19 booster which is Phizer on Thursday 10/21/21 Friday 10/22/21 I reacted very badly I couldn't stand for more than 5 minutes during my work hours, I was nauseated and basically felt I like someone knocked me to the bed. I went home at 9:17 am I went straight to bed  I woke up legs ached I couldn't get comfortable. Too Tylenol and I got some better. I improved by Saturday night 10/23/21 . I still feel effects like my legs hurt after a 8 hour shift of work 10/25/21 which I don't believe this is normal.
Patient states on 12//17/07 approximately 8:30 AM the injection site began to itch and swell.  By 6:00 PM, she felt flushed from her chest to her neck, weak, dizzy and had difficulty swallowing.  She took 50 mg Benadryl and called the paramedics who advised ER visit.  She was seen at hospital, given Claritin and Prednisone but still symptomatic
Initial report received from the patient's parent on 04 November 2010. This is a case of misuse where expired vaccine was administered. A healthy 5-year-old female patient had received a third left deltoid injection of expired DT ADS PED USP vaccine (lot number U2105BA, expiration date 29 January 2010) on 03 November 2010 at 17:00. The following day around 5:00 am, 12 hours-post vaccination, the patient woke up with vomiting, temperature of 102.0 degrees Fahrenheit (T102), headache (HA), and as irritable (whiny). The patient's physician was called and the patient was prescribed TYLENOL. Per the reporter, the length of the needle used to administer the vaccine was unknown. At the time of this report, the patient had not recovered. Documents held by sender: None.
sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking what should she do since she was sick (just got it a few days ago) and today (day of report) was her second dose. It was reported that she can't get the second vaccine right now and wondered what to do.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After leaving the clinic -after the wait time, Pt developed a scratchy throat, pain with swallowing, shortness of air- she took 2 Benadryl and then went to the ER. She was given  famotidine, solumedrol- monitored and sent home on  and oral steroids.
Pt presented with headache 15 minutes after first COVID vaccine.  Comfort measures offered.  BP 122/74 O2 98% Temp 98.5 P 88.  Tylenol 325 2 tabs po given with good results within 10 minutes of administering.  Follow up call to patient positive. No resumption of pain as of 9/24/2022
vomiting, diareha, fever,, faintness, shortness of breath,  hospitalization requiring blood transfusion  systomatic anemia
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unspecified dates on or after 23-NOV-2015, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L026410, expiration date 15-FEB-2017, strength, dose, dose# and route unknown). No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician's staff member concerning a male patient (age not reported) who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently, after vaccination, the patient developed a rash. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician's staff member and a physician concerning a 96 year old female patient (previously reported as a male) who on an 05-DEC-2006 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot # 052965/0622F) in right deltoid. On 24-JAN-2007, the patient developed shingles had diffuse varicella like pruritic rash two-three weeks prior. Subsequently, the patient recovered. Additional information is not expected.
Stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000000360 (Novavax).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke". Follow-up attempts are completed. No further information is expected.
I had an upper respiratory infection in October 2022. I was prescribed Flonase, and I was sick for about ten days. I got a second upper respiratory infection in December 2022, and it turned into acute bronchitis. I was sick for six weeks. I was tested for COVID-19 and influenza, and the results were negative on both. I received azithromycin, a steroid shot, and promethazine. I was still sick a couple weeks afterwards, and I was prescribed doxycycline, a Flonase inhaler, and an albuterol inhaler. I then gradually got better after that. In February or early March 2023, I got another upper respiratory infection. I was prescribed azelastine nasal spray and a steroid inhaler. I was tested for COVID-19 and streptococcus, and the results were negative on both. At the time of this writing, I have been dealing with this for about two weeks. I still have a lot of nasal congestion and a cough, but I otherwise feel fine.
Vaccinated 10/09/2002. On 10/15/2002 macules papular rash on thighs and abdomen with ? candela dermatitis. Tx with Benadryl po and Lotrimin topically. 10/22 rash noted that comes and goes along with tinea capitis Tx with Griseofulvin 10/28 seen with rash- told to stop Grisenfulvin. Papules with vesicles that come and go. Thought to have varicella 2 hours after vaccine. Refer to I. D. Dr. 10/30/ Infectious Disease consulted who Dx varicella vaccine adverse event along with Tinea Capitis. Rash presented still on 10/30/2002, but was resolving.
chills/sweats; dry heaving; chills/sweats; sore arm at the site of the injection; This spontaneous case was reported by an other and describes the occurrence of HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection). On 25-Feb-2021, HYPERHIDROSIS (chills/sweats), RETCHING (dry heaving), CHILLS (chills/sweats) and INJECTION SITE PAIN (sore arm at the site of the injection) had resolved.            No concomitant medications were reported.  No treatment medication were reported.