chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 23-SEP-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot# L039095 and expiration date: 08-JAN-2017 (dose and route of administration were not reported) reconstituted with sterile diluent. There were no adverse effects reported.
Within 30 minutes employee complained of wrist and lower arm hurting. There was not swelling or redness or itching. No treatment. Symptoms subsided.
ONE PATCH OF HAIR LOSS APPEARED WITHIN 30 DAYS OF VACCINE ADMINISTRATION AND CONTINUED TO INCREASE OVER THE NEXT COUPLE OF MONTHS. BY TODAY OVER 50 PERCENT OF HEAD AND FACIAL HAIR HAS FALLEN OFF.  VARIOUS STEROID TREATMENT HAVE BEEN ADMINISTERED WITHOUT ANY IMPROVEMENT.
This case was reported by a healthcare professional to a sales representative and described the occurrence of the redness and swelling at the injection site in a 4-year-old subject (unknown gender) who received diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On an unspecified date in either in March 2006 or April 2006, the subject received the 5th dose of Infanrix in an unspecified thigh (lot AC14B018AA). On the same day, the patient received injections of poliomyelitis virus vaccine (IPOL, Aventis Pasteur) and measles mumps and rubella virus vaccine (M-M-R II, Merck). the injection sites for IPOL and MMR II were not provided. At an unspecified time after vaccination with Infanrix, on an unspecified date on or before April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was no reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Information has been received from a nurse practitioner concerning a 19-month-old Hispanic male with no known drug allergies and with otitis media who on 29-Dec-2003, at 18-months-old, was vaccinated in the right deltoid and with a first dose of varicella virus vaccine live (lot3 646360/0571N). Concomitant therapy from 23-Dec-2003 included ceftriaxone sodium (Rocephin) for otitis media. On 13-Jan-2004 the patient presented to the physician's office with a full blown case of chickenpox, described as a papular rash, a few vesicles, and some scabs on his face and trunk. It was also noted that there was left ear drainage, and that the patient had a slight fever. The outcome was reported as not recovered. It was noted that the non-vaccinated, 4-year-old sibling of the patient had a case of chickenpox toward the end of December 2003. No other information was given. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a nurse practitioner indicated that the patient recovered. No further information is expected.
Broke out in a rash (small, red bumps) on her face, 11 days post-vaccination. The rash then spread to her trunk, and later extremities. By 13 days post-vaccination, the rash became raised, red bumps covering her entire body. Diarrhea and fever (low grade) accompanied the rash.
Feeling tingling arm, leg, hand, feet and sometimes other parts of body; Some numbness; 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 PARAESTHESIA (Feeling tingling arm, leg, hand, feet and sometimes other parts of body) and HYPOAESTHESIA (Some numbness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Feeling tingling arm, leg, hand, feet and sometimes other parts of body) and HYPOAESTHESIA (Some numbness). At the time of the report, PARAESTHESIA (Feeling tingling arm, leg, hand, feet and sometimes other parts of body) and HYPOAESTHESIA (Some numbness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported  No treatment medication was reported   Reporter did not allow further contact
Swollen Lymph node in arm pit. Minimal discomfort and soreness in armpit/lymph node. No pain.  Swelling seemed to start around a week after 1st dose. Swelling  has subsided in the past few days.
dermographia with welts & hives; dermographia with welts & hives; This spontaneous case was reported by an other health care professional and describes the occurrence of MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of UNK UNK, qd. At the time of the report, MECHANICAL URTICARIA (dermographia with welts & hives) and URTICARIA (dermographia with welts & hives) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD22-005475 (Patient Link).
GBS; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program Support. This consumer reported similar events for six patients. This is the second of six reports. This patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. On unspecified date, the patient developed GBS (Guillain-Barre syndrome) after getting the vaccine. The reporting consumer wanted to know if there were reports of GBS and also wanted to know if she could speak to someone about GBS reports. The reporting consumer mentioned that she knew 6 people who developed GBS after getting the vaccine. Outcome of the event was unknown. This report was assessed by the reporting consumer as non-serious.   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) :PFIZER INC-202101332906 same reporter/drug/event, different patients
Eczema to flare up; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema to flare up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Eczema.    Concurrent medical conditions included Eczema.   In 2020, the patient started DUPILUMAB (DUPIXENT) (unknown route) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema to flare up). At the time of the report, ECZEMA (Eczema to flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that he just wanted to report what he thought was a reaction he had after receiving first dose of Covid-19 vaccine. It caused his eczema to flare up and even after administering dupilumab shot it seemed to not be effective at all. He had been taking dupilumab for a little under a year with great success up until he received chicken vaccine. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Product details and event information updated.
MUSCLE ACHES AND PAIN, GENERAL MALAISE AND EXTREME  WEAKNESS.OUT OF WORK FOR 3 1/2 DAYS. HAD HAD VACCINE TWICE BEFORE AND HAD MODERATE LOCAL REACTIONS WITH ARM SWELLING AND PAIN.
Hotspot/Red circle on my right arm, not on the injection site.  Was bigger today than yesterday when I noticed it.  No other issues, just swollen and hot with a large red circle.
Swelling, redness, itching, hot, hard lump. Symptoms increased and grew from localized injection site to include medial aspect of the elbow to the arm pit and the entire posterior aspect of the upper arm. Doctors office called on 2nd day and instructed by nurse to take Benadryl. Took for 3 days and stopped when there was about 1 inch of normal color to posterior of upper arm. Symptoms existed for 7-9 days and remained extremely uncomfortable. The area continues to be sensitive but has decreased as the days have gone by. The sensitivity is similar to the SHINGLES I had in 1999.
Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 18-DEC-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J01402 and expiry date: 13-NOV-2015 which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No average effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
Body aches; Pain at injection site; Lethargy/ Need to sleep; This is a spontaneous report from a contactable consumer. A 48 year old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration on the right arm on 16Mar2021 at 08:45 as a single second dose for COVID-19 immunisation (at the age of 48 years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration in the right arm on 23Feb2021 at 08:45 as a single first dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On 24Feb2021 patient underwent lab test which included nasal swab test and result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021 at 13:00, the patient experienced events feverish (99-100F), body aches across entire body, pain at injection site and lethargy (Need to sleep). The patient did not receive any treatment for the events. The clinical outcome of the events body aches, pain at injection site and lethargy were recovering at the time of reporting. Since the vaccination the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Very high fever, sore throat. My 12 year old son received his first dose of GARDASIL. 48 hours later, has a sustained fever of 103.1, severe aches and chills, and sore throat.
Pfizer-BioNTech COVID-19 Vaccine EUA On day 10 after the injection I was itching all over my body.  There were red welts on fragile areas of my skin.  I do have sensitive skin.  It lasted 2 days and went away on its own.
Felt achy with a headache when I woke up Saturday morning after having the shot the day before. The injection site is extremely sore and red with raised bump. Took 2 ALEVE and achiness seemed to ease... Pain at injection site continues as well as red and raised bump. Sunday was better but still had headache and felt tired. Injection site still red and very sore with raised bump. Monday feeling tired...Injection site still very sore and red with raised bump. There is beginning to be itching around the bump...too painful to really scratch.
Information has been received from a LPN concerning her husband, an adult male, who several years ago was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The LPN reported that she gave her husband the vaccination with pneumococcal 23v polysaccharide vaccine and he developed redness and swelling at the injection site. No treatment was required for the adverse event. The adverse event abated and the pt recovered. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Oka-Merck) injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. No adverse effect was reported. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
About 20 minutes after receiving the flu shot, pain and discomfort spread from arm across into shoulder front chest above heart to back into side of neck then up neck. It gradually spread across neck and chest to just past mid line on her chest and around her whole neck. Making it feel difficult and tight kind of swollen like when breathing. 2 Benadryl were given in 20 min. intervals per the pharmacists recommendation then the Drs office was called patient then was taken to ER per both the pharmacist and Drs. recommendation. The ER Dr. determined it was a pneumomediastinum and said it was a coincidence it happened at the same time as the vaccine but she had NO SYMPTOMS prior to the shot and the symptoms shoed up 20 minutes after the shot!!!
Rash about the size of a Kiwi. Patient reported itching and heat around area---no fever and no joint or muscle pain was reported when I asked her.  Rash was red and white in color.
Headache/All she got was a headache; This is a spontaneous report received from contactable consumer (Patient's husband reported for female consumer reporter's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA-1273 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache/all she got was a headache on 08Jul2021. Reporter stated his wife got another vaccine. She got the Pfizer shot. All she got was a headache. Reporter wife received Pfizer Covid-19 vaccine. He reports she experienced a headache. Outcome of the event was unknown.  Follow-up attempts have been completed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 08-FEB-2013, the patient was administered an expired dose of live ZOSTAVAX (lot#165744; exp., date: 21-JAN-2013) (dose and route not reported). The outcome of the event was not provided. The relatedness of the event with live ZOSTAVAX was not provided. Additional information has been requested.
Left shoulder soreness (Started before 9pm but don't remember when).  Fatigue, body aches, headache.
Headache from early morning (about 2am ) until approx 5pm the following day. Chills, tired, general malaise.
Erythematous, hot, 5cm x 7cm placque at injection site of PNEUMOVAX and influenza vaccine.
24 hours after vaccine administered, child developed shakes. States had jerking movements lasting 10-15 minutes each hour for 2-3 days. today 12/06/2005 jerking movements have improved, has a slight movement that now occurs occasionally.
I am working a first responder and out of all my coworkers I was the last one to contract COVID-19. I have been exposed so much due to my work I just test regularly. I did a at home test on 12/12 and then again with a PCR 12/16 and antigen all which were negative. On 12/17 I had; a drippy nose loose stool and I have had allergies since I was 4 so I thought it was normal. On the 18 10am I started having a cough and at noon I had a headache in between my eyes. Then as soon as I finished my shift I went to the local ER. I waited because on shift requires supervisors fire department EMT escorts along with lots of paperwork. I got a chest x-ray and did a COVID-19 test which was positive. I was prescribed Paxlovid started on Monday, and I took Ibuprofen for the headaches. The hardest part was the headaches requiring three rounds to get it under control. I was still having body aches along with loose stool.
Moderna covid-19 vaccine EUA Knot, redness, itching, hot at injection site,
throat swelled on the right side; tongue swelled; TONGUE SWELLED MAKING IT DIFFICULT TO SWALLOW.; NOW HAVE LOST MY SENSE OF TASTE AS A RESULT OF THIS REACTION.; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20Mar2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and drug allergy (Narcotics allergy). Concomitant medications included furosemide (LASIX), and meloxicam (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unspecified date at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Mar2021 at 12:00 the patient experienced throat swelled on right side and tongue swelled, making it difficult to swallow. Had lost my sense of taste as a result of this reaction. The patient did not receive any treatment for the events. The clinical outcome of the events throat swelled on right side and tongue swelled, making it difficult to swallow. Had lost my sense of taste as a result of this reaction was recovered with sequelae.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient stated she was "feeling dizzy and felt like passing out"  after receiving the Afluria vaccine as her Pfizer vaccine was administered. She started with rapid  eye roll, lost consciousness, stiff movement of arms and legs, and fell backwards on head. 911 was called and she was taken to hospital
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: convulsion-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: patient recieved first dose, went to go sit in observation area, few minutes later fell forward off his chair and starting having a seizure. called 911. patient was able to get up and sit in chair with feet elevated. paramedics came, patient refused hospital visit. Patient was oriented and went home after the paramedics.
This case was reported in a literature article and described the occurrence of anaphylaxis in a 6-year-old female subject who received Flu seasonal TIV Dresden. This case refers to patient 21 in the literature article. The subject's past medical history included anaphylaxis, allergic rhinitis and reactive airways disease. Previously experienced adverse reactions included flu vaccination. On an unknown date, 1 hr after receiving Flu seasonal TIV Dresden, the subject developed anaphylaxis. Serious criteria included GSK medically significant and life threatening. Additional event(s) included red throat, generalized pruritus, generalized rash and cough. The subject was treated with epinephrine and antihistamine. The outcome of anaphylaxis was recovered/resolved. The outcome(s) of the additional event(s) included red throat (recovered/resolved), generalized pruritus (recovered/resolved), generalized rash (recovered/resolved) and cough (recovered/resolved). The investigator considered that there was a reasonable possibility that the anaphylaxis, red throat, generalized pruritus, generalized rash and cough may have been caused by Flu seasonal TIV Dresden. Additional information was provided: This case was reported in a literature article and it described the occurrence of a vaccine-triggered anaphylaxis in a 6-year-old female patient who had received an unspecified trivalent influenza vaccine (manufacturer unknown). The patient was a female. The subject's medical history included atopic disease with anaphylaxis, allergic rhinitis, reactive airway disease and trivalent influenza vaccine allergy. No further information on the patient's concurrent medical conditions, medical or family history, or concomitant medication was provided. On unspecified dates, between the 1st of January of 2009 and the 31st of December of 2011, the patient received 5 test doses of an unspecified trivalent influenza vaccine (dosages unknown; administration routes and sites unspecified; batch numbers not provided). On an unspecified date, within 60 and less than 90 minutes after the 5 test dose vaccination, the patient developed throat erythema, generalized pruritus and rash and cough. This was classified as anaphylaxis by the allergist. According to the authors the case was considered as Brighton level 2 and setting of initial evaluation was clinic. The patient was treated by epinephrine and oral antihistamine. At the time of reporting the outcome of the events was recovered. This event was classified as vaccine related according to the authors. The authors concluded that "Anaphylaxis after vaccination is rare in all age groups. Despite its rarity, anaphylaxis is a potentially life-threatening medical emergency that vaccine providers need to be prepared to treat. This case is 1 of the 28 valid cases reported in the same literature article.
The pt developed pancreatitis after receiving 1st dose of hepatitis vaccine in 1997.
Narrative: Patient reported feeling faint after administration of 1st dose of covid vaccine. Patient was released with no additional intervention needed.
pt stated immed after inject of vax devel sore arm, several days later devel knot inner aspect of la w/a knot in arm just above elbow crease, swelling, tingling. numb/tingling cont 5/10, 5/18 sx are less but knot still present &aching arm