chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID arm for 1 week (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and Wound care for Vaccination site reaction. At the time of the report, VACCINATION SITE REACTION (COVID arm for 1 week (1st dose)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient did not have allergies.  Concomitant medications were not provided by reporter.  Patient's received Cold showers as treatment.   This case was linked to MOD-2021-428091, MOD-2021-428092 (Patient Link).
Both injection sets were painful for three days. Nausea, Vomiting, headache, diarrhea, loss of appetite that has been continuous. Also, chronic fatigue and tiredness, muscle and body aches. Its been miserable.
This spontaneous report as received from a registered nurse 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 unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB injection (lot# K008679, expiry date 05-MAR-2017 and lot# K015464, expiry date 09-JUL-2017; exact dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt stayed in recovery area 15 minutes after immunization, felt fine when leaving, but then became diaphoretic, and nauseated, sat down on floor.  Blood pressure was measured at 10:53am was 68/37.   Patient was able to maintain normal breathing and was conversational.  Pt stated he did not eat anything this morning.  Was given crackers and water.  EMS was called. Blood pressure remeasured upon EMS arrival 108/70 at 10:59am.  They then took over assessment.
Headache, nau/vom, muscle ache, throat tightening when vomiting
Breakthrough COVID; Breakthrough COVID; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 21Oct2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he took Pfizer vaccine few weeks prior to the initial report on 20May2021. He had no immunity for COVID in his blood wok on an unspecified date. On 21Oct2021, the patient reported that it (vaccine) does offer protection. If you get a breakthrough COVID you are expected to experience only mild symptoms. The patient had seen this first hand already. It (vaccine) beats death and long COVID. The outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Approx. 24 hours after receiving 1st Moderna dose I started to have trouble breathing with constriction in the area of my lower lungs/diaphragm.  Trouble breathing & constriction continued to worsen over the following 8 hours at which point I called EMS and was taken to the emergency department at a local hospital.  Chest x-ray showed some hazy opacifications in both my lower lung lobes.  I was given a breathing treatment and an injection of Toradol.  After I returned home, trouble breathing, constriction, and mucus accummulating in lower lobes of my lungs continued - for several weeks.  I had to use my Albuterol inhaler every 4 hours, take an expectorant and a NSAID - every day - for nearly 4 weeks before I finally started to feel better.  This was a real ordeal for me to get through.  I have had asthma all my life and COPD for +30 years.  Whenever I catch even the simplest of colds, it always hits me in the lungs, mucus accummulates in my lungs very rapidly & sometimes leads to a bacterial infection, I struggle to breathe, and it takes me weeks to recover.  I was afraid of getting one of the Mrna vaccines because I worried this might happen - and it did.  I am extremely afraid of & cannot get the 2nd Moderna dose because I believe there is a strong possibility I may have an even worse adverse reaction.  If I catch this terrible virus, it will kill me.  I am praying new, NON-MRNA VACCINES, will be developed soon for people like me.  These Mrna vaccines are too dangerous for someone like me with COPD & how my immune system reacts to it.
pt presented to ER w/diffuse skin rash which began 10min p/vax;pt initially c/o pruritus, rash evolved on face & spread to arms;med given;next day further eruption & wheezing;atarax given;
Initial unsolicited report received from non-healthcare professional on 29-Feb-2016. This case is linked to 2016SA041761 (same reporter). This case involves a 7-8 patients who were vaccinated with an intramuscular dose of INFLUENZA QUADRIVAL A-B VACCINE (Fluzone QIV) (batch number and site of administration were not reported) on an unspecified date in 2015. Illness at the time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On an unspecified date in 2015, after vaccination, patient's tested positive for an A virus and had become sick with flu. Lab tests and corrective treatments were not reported. Outcome was reported as unknown. Upon medical review, the case was considered as serious due to important medical event: influenza A virus infection, sickness and vaccination failure. Documents held by sender: none. Sender's Comments: As with any vaccine, vaccination with influenza vaccine may not protect 100% of susceptible individuals. However, additional information on the patient's immune status at the time of vaccination (medical history, concomitant medication), the time to event onset, previous vaccinations, infectious work-up results and details of tests used to identify the influenza strain (e.g. PCR, nasal swab, etc.) are needed to further assess this case.
This spontaneous prospective pregnancy report as received from a physician refers to a 24 year old female patient, regarding GARDASIL, the Pregnancy Registry Product. On 08-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (intramuscular injection)0.5 mL once (lot # not reported). The patient was pregnant at vaccination (LMP: 27-NOV-2012; EDD: 03-SEP-2013). No adverse effects reported. The patient sought medical attention, it was an office visit. Follow-up information was received from the physician concerning the patient with no concurrent medical conditions and a history of obesity. On 08-JAN-2013, the patient was vaccinated with a first dose of GARDASIL (lot # H016960, expiration date 02-DEC-2013). Concomitant medication included vitamins (unspecified) ("prenatal vitamins") and coal tar (NEUTROGENA T/GEL). Additional information has been requested.
I developed mild hives several days after the first shot, but I didn't know that this was an allergic reaction. Once I received the second shot on 1/6/21 (not knowing I was already allergic to it), a few minutes afterwards, my throat swelled up and felt tight. The next day, the hives were out of control all over my body and I kept having episodes of SOB and dizziness so I went to the ER again where I was put on a high dose of prednisone and Benadryl. I had a total of 3 rounds of prednisone and was seen in either the ER or Urgent Care 3 more times after this for the same thing. I've tried every Over-the-counter allergy medication, cream and ointment, have been seen by my PCP, a Dermatologist, have had steroid injections, an now followed by an Allergist and am on Immunotherapy injections every 3-4 weeks. Eight months later, I still have hives, my immune system is weakened, I get frequent UTIs and kidney infections, and my migraines are more severe and more frequent now. I have lost a lot of time at work because of it and have two disability claims out as well.
Information was received on 28-JUN-2017 from a Licensed Practical Nurse (LPN) who was reporting on a 15 month old female patient. Relevant medical history and drug history included acid reflux treated with omeprazole (manufacturer unknown) (dose, route, frequency and formulation not reported) from  an unknown date. On 27-JUN-2017, the patient received a dose of PROQUAD (lot M046943, expires 27-MAY-2018) (dose and route not reported) and a dose of VARIVAX (lot M043305, expired 26-OCT-2018) (dose and route not reported) by mistake and therefore the varicella was duplicated. The patient will be observed and has had no complications. Additional information has been requested.
(12/21/20)Dose #1: slight redness and swelling at the site for about 24 hours. Day 9-because extremely itchy, red and swollen. Headache, diarrhea, abdominal pain and nausea for about 6 hours.  (1/15/21)Dose #2: less than 24 hours after injection, site was red, warm, swollen, itchy. Severe muscle/body aches. Temp was 100. Injection site developed the size of a softball red, warm, itchy and firm area. The entire next day, extremely fatigued and muscular pain. Today 1/18 (site is still inflamed and itchy)headache and neck stiffness.  Prior to my injection I was having joint pain in my ankles and being right knee, so I made an appointment for today not realizing I was getting the vaccine on Friday. So lab tests were ran today.
A physician reported (by a sales representative) that a 9 month old child received the 2nd dose of Prevnar and subsequently, developed invasive pneumococcal bacteremia. As of 5/2/01, no further information was available. Septicemia streptococcal is considered "Medically Important". Follow-up info received on 06/25/2001 indicated that a 9 month old female received her second dose of Prevnar on 03/13/2001. On 04/27/2001 at 10 months of age, she presented to the physician with irritability and fever. Her physical examination was normal; complete blood cell count, urine and blood cultures were obtained. White blood cell count was 25,100 with segmented neutrophils at 25, bands at 16 and lymphocytes at 23. Her hemoglobin was 12.0 with a hematocrit of 35.3. Urine culture was negative; her blood culture was positive for stretococcus pneumoniae. A diagnosis of pneumococcal bacteremia was made. The pt was treated with ceftriaxone socium and subsequenty with amoxicillin; she recovered. From follow up: Cancelled- This case has been found to be a duplicate of HQ0472203May2001 which will remain the case of record.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot#, dose, route unspecified) on 15-OCT-2012 that was exposed to a temperature excursion but the time and temperature associated with that excursion had not yet been determined. No adverse effect reported. The outcome was unknown. Additional information has been requested.
18 HRS AFTER VACCINATION  PATIENT DEVELOPED MACULOPAPULAR RASH NON-TENDER, PURPLISH OVER LEGS, ABDOMEN, ARMS AND THORAX. PRESCRIPTION GIVEN FOR TOPICAL STEROIDS AND ANTIHISTAMINES (TOPICAL AND OPHTHALMIC)
Severe migraines and stiffness in the back of the neck after receiving Botox injections for migraines 8 days after 2nd dose of Pfizer. The back of the neck where the injection site of the Botox occurred, locked up for for several days and swelling occurred. Shortness of breath also occurred over a four day period.
tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete., Manufacturer unknown), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After 6 days after my first dose of Pfizer I broke out in hives on my elbows and knees. I would wake up with new hives every day on all my joints. After my second dose my hives progressed and ever since has slowly become worse. The hives spread all  over my legs and arms and very rarely on my abdomen. These hives will not react to antihistamines .
The patient passed out after 10 minutes after feeling really hot and sweating.    He became conscious in less than a minute and was feeling okay.
I had limb weakness after the shot that has now progressed to CIDP and use of a cane to walk
5/7 "Nipple area" very uncomfortable on side of vaccine administration, c/o Prickly" feeling. No rash wonder if shingles. Advised to contact PCP. PCP (OB/Gyn) advised he to watch I said it was a reaction to the vaccine 5/8 "subsiding"
Tachycardia "scratchy throat, fuzzy feeling tongue neck beginning to swell" Narrative:  monitored for 4 hours and discharged to home with epi pen,
headache; severe neck and shoulder pain; severe neck and shoulder pain; intense fatigue; arm was first very achy; shooting pain; redness; "hot" to touch; This is a spontaneous report from a contactable healthcare professional reporting for herself. A female patient of an unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient reported that her blood type was O positive. The patient previously received the first dose of BNT162B2 on an unknown date. On an unknown date, the first day after receiving the second dose of vaccination, the patient experienced headache, severe neck and shoulder pain, and intense fatigue like jetlag x10. On an unknown date, the patient experienced her arm was first very achy, then shooting pain, burning pain, and the past two days, redness, and very "hot" to touch. There was no cellulitis and no sign of infection.  The patient was on day 4 and still experienced fatigue. The outcome of the other events headache, severe neck and shoulder pain, arm was achy, shooting pain, burning pain, redness, and "hot" to touch was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Described as:  hives on the chest, neck and left shoulder where the injection site was.  Lasted until 10/4/19.  Person did not seek medical attention/assessment.  Treated self with Benadryl.
Pfizer-BioNTech COVID-19 Vaccine EUA Uncontrollable chills  started about 12 hrs after getting vaccine, lasted about 3 hrs. General chills, tiredness, headache, muscle pain, fever, some joint pain, nausea for the next 24 hrs. Fever of 99.8-100 during all this time. Heavyness and ache in lower left arm and hand
Developed Rash all over abdomen, trunk ,back and below breast and legs about 2 weeks after the Moderna Booster These rash are about dime size , but varied in shape, redish, flat Itchy and some a little flaky. Turn to a dark color later on almost black . Couple of weeks after first  rashes, developed more rash but only on forearms , small red dots Raised and bumpy, itchy
EXPIRED VACCINE ADMINISTERED FROM THE VIAL AFFECTED FROM TEMPERATURE EXCURSION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808986 expiry: 02-OCT-2021) dose was not reported, administered on 04-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-JUN-2021, the patient experienced expired vaccine administered from the vial affected from temperature excursion. On 04-JUN-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the expired vaccine administered from the vial affected from temperature excursion and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210913164, 20210915623, 20210915646, 20210915661, 20210915719, 20210915748, 20210915852, 20210916228, 20210916312, 20210916300, 20210916455, 20210916553 and 20210916520.
Case number PHEH2016US034237 is initial spontaneous report received from nurse on 27 Oct 2017. This is also a quality complaint report (QA reference number: 1017561). This report refers to 50 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1619521, expiry date: 02 Apr 2017) at a dose of 0.5 ml intramuscular on 27 Oct 2016. The nurse reported that the patient received dose from leaking multi dose vial. The patient received a full dose. No vaccine leaked on patient or administrator. It was stated that, when drawing up vaccine out of multi dose vial it seems to be much pressure in the vial and the vaccine was dripping out from the rubber stopper; needle sized being used 25 gauge 1 inch. No adverse event was reported following this medication error. The case was assessed as non serious by the nurse. Batch review report reference number [1017561] received from quality assurance department on 14 Dec 2016. Based on the document review, it was stated that the concerned FLUVIRIN batch number [1619521] was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from Quality assurance department (QA reference number: 1017561) on 14 Dec 2016: Added QA investigation summary.
The following day was a bit, tired so rested, and 1.5-2 days exhausted. General feeling of unwell. Slept most of the day. Not hungry. Dizzy. Nauseous.   ~ month later I began having migraines with vertigo, tinnitus and paresthesia....
Ulcers on both side of tongue; A red rashy patch on the injection arm; A red rashy patch on the injection arm; That is sore to the touch; Hurt him to get up; Feeling Ill; Back pain; Sluggish; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue) and PAIN (Hurt him to get up) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VERAPAMIL for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced MALAISE (Feeling Ill), BACK PAIN (Back pain) and SLUGGISHNESS (Sluggish). On 12-Jun-2021, the patient experienced PAIN (Hurt him to get up). On 15-Jun-2021, the patient experienced TONGUE ULCERATION (Ulcers on both side of tongue), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch). The patient was treated with IBUPROFEN at a dose of 800 milligram. At the time of the report, MALAISE (Feeling Ill), BACK PAIN (Back pain), SLUGGISHNESS (Sluggish), TONGUE ULCERATION (Ulcers on both side of tongue), PAIN (Hurt him to get up), VACCINATION SITE ERYTHEMA (A red rashy patch on the injection arm), VACCINATION SITE RASH (A red rashy patch on the injection arm) and VACCINATION SITE PAIN (That is sore to the touch) outcome was unknown.            This case was linked to MOD-2021-222399 (Patient Link).
"Kicked her ass" after the second dose; Felt nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt nausea). At the time of the report, MALAISE ("Kicked her ass" after the second dose) and NAUSEA (Felt nausea) outcome was unknown.            Concomitant product details was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: TCR Received : Contains No New Information
Shortness of breath with a crackle sound which became more pronounced when lying down.  I sat upright for about 1.5 hrs and respiration returned to a normal rhythm at which time I was comfortable enough to return to bed.  I did not seek medical attention but monitored closely during that time and was prepared to go to the ER if necessary.  As I write this I am at 22 hrs post vaccination.  Respiration is fine, I have some discomfort at the injection site, a slight headache and some aches and pains which is expected.
Headache, fatigue.  Reports that throat started feeling "swollen right away" after vaccine but chose not to alert staff, "didn't want to bother anyone".  Spoke with pt today over phone, 3.19, states he still has this sensation.  Advised to seek care ASAP, declined at this time.
Breakthrough case admission after three vaccines 1/22/21 Pfizer Lot# EL3249 2/12/21 Pfizer Lot# EL9267 12/7/21 Pfizer Lot# FJ8757
5/14/13 I received call from client. She had received a tetanus shot on 3/21/13 at our clinic. Reported she has had severe joint pain since tetanus shot was given. Client declined to complete the VAERS form. Stated, "I need to talk to someone else before I answer anymore questions."
mom said that arm was red where the shot was given rt arm;MMR was given SQ in rt arm;
I did not have any reaction at time of vaccine however one week later I developed rash, swelling, pain and redness at site of shot.
0.2mL of non-diluted Pfizer Biotech COVID 19 Vaccine Peds vial