chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was almost in menopause before I received my first dose of the pfizer vaccination on January 21, 2021. (I had not had a period for close to 8 months at that time) Two days after my 1st vaccination I got my period. It was pretty painful and very heavy and lasted close to 10 days. Then again, right after my second dose, which was only three weeks later, I got a period that was painful, heavy, and lasted longer than normal.I received my booster this past Friday, 10/15/2021. The next day I started spotting and today (2 days after Covid 19 booster) I have a full period.
Low-grade fever; severe joint/muscle aches; severe joint/muscle aches; headache; loss of taste; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 18Dec2020 at single dose in right arm for covid-19 immunization. Medical history included hypertension and anxiety. No other vaccine was received in for weeks. Concomitant medications in two weeks included losartan, famotidine, aspirin (acetylsalicylic acid), prazosin, escitalopram. The patient did not have COVID prior vaccination and patient did not underwent COVID tested post vaccination. The patient experienced low-grade fever, severe joint/muscle aches, headache, loss of taste on 19Dec2020 01:00. The patient did not receive any treatments of the events. The outcome of the events was recovered on an unspecified date.  Information on Lot/Batch has been requested.
Red face; feeling hot on her body; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face) and FEELING HOT (feeling hot on her body) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA (Red face) and FEELING HOT (feeling hot on her body). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Red face) and FEELING HOT (feeling hot on her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.    This case was linked to MOD21-055557, INC.-MOD-2021-046664 (E2B Linked Report).; Sender's Comments:  MOD21-055557:Crosslinked husband case, INC.-MOD-2021-046664:Crosslinked husband case
Redness, swelling, itching, sneezing, coughing, body aches at site of injection. Came to pharmacy with script for anti-inflammatory.
COVID-19 Vaccine EUA; Arm?s vaccine site became swollen, hard & red on 2/13-2/15.  On 2/13/21, developed chills by 7:30 pm. On 2/14/21, same symptoms as 2/13/21, but placed ice bag on arm.  On 2/15/21, vaccine site became a larger area which was swollen, hard, red and itched. that evening, put Benadryl cream on red arm area, also had chills that evening.  On 2/16/21, vaccine site was a small red circle, swollen just slightly, did not itch.
3RD DOSE MODERNA COVID VACCINE GIVE 11/09/2021, #034F21A; pt had a positive COVID test on 8/15/2022; pt has been hospitalized 2x in past month; recent dc was 9/6/22; pt presents on 9/8/22 with SOB, generalized weakness, malaise, Nausea, vomiting, diarrhea, loss of appetite; pt required intubation; transferred to ICU; AHRF and severe sepsis; minimal improvement; pt requested to be palliatively extubated; extubated; DNI/DNR, comfort care; she passed away in the hospital
I experienced a breakthrough case of COVID-19 with fever, chest congestion, tiredness and body aches.
This is a spontaneous report from a contactable physician through a Pfizer Sales representative. This physician reported similar event for two patients. This is first of two reports. An adult patient received PREVNAR 13 on arm, unknown date for immunization. Relevant medical history, drug history and concomitant medications were unknown. On unknown date, the patient experienced injection site reaction. Therapeutic measures taken in response to above mentioned event included treatment with unspecified steroid for one week. Sibling information was unknown. Relevant lab data was unknown. At the time of the report the patient was recovered from above mentioned event on an unknown date. Follow-up (25NOV2012): Follow-up attempts completed. No further information expected.
No additional AE reported; the vaccine was administered while out of recommended range; This spontaneous report was received from a registered nurse referring to a 6 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.                  On 15-MAY-2021, the patient was administered with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, strength was not reported, valid lot # 1694410, expiration date 19-DEC-2021) orally for prophylaxis while out of recommended range. The vaccine administered experienced a temperature excursion of 89 Fahrenheit, with time frame 24 hours. There was no previous temperature excursion. A digital data logger was involved.  No additional adverse event was reported.
Noted inc cough and tachycardia 1 hour after injection. Did not require medical treatment. Repots consuming lagrge amts of caffiene as well.   Narrative:
Red, raised, warm and itching at injection site. Size 45mm x 28mm. No wheezing or difficult breathing. Temp 97.6.
I received the second dose of the Pfizer vaccine on Friday April 9th at 6pm. I did not feel any adverse effects beyond arm soreness around the injection site until the morning of Sunday April 11th, at which point I had exacerbated joint pain (likely an inflammation response). In the evening of the 11th, I noticed the soft tissues of both my mouth and vulva felt more raw/sensitive than usual. On the 12th this feeling persisted, with canker sores/mouth ulcers forming in my mouth/throat and a continued stinging/irritated feeling in my vulva. On the 13th this manifested as vulval ulcers, which were painful on their own and with pain dramatically increased while urinating. During the night of the 13th/morning of 14th I also woke up several times feeling either chilly/clammy or overheated, and took 800mg ibuprofen and slept through to the morning of the 14th. By the time I woke up I no longer had chills/fever symptom, but mouth and vulval ulcers had both progressed. The appearance of the vulval ulcers was crater-like patches with a white coloration surrounded by raised red rims, with several touching/against each other and surrounding tissue also inflamed/sensitive. On the 15th I made an appointment with urgent care as I was unable to use the bathroom without extreme pain and was unable to wipe the area and had to rinse in the shower to stay clean instead. From the Urgent Care clinician I was prescribed a 5% topical lidocaine ointment, a 4% over the counter lidocaine alternative option, and an antiviral course of Acyclovir. Bloodwork was done to rule out STIs. Applying the ointment 4-5 times a day before using the bathroom was the most effective part of treatment, although constant discomfort and inability to wear tight clothing/wash the area normally persisted for the following week. At peak, there were 10 visible ulcers ranging from 0.3cm-0.8cm in diameter, located on both inside sides of the labia and with some presenting as "kissing sores". After April 20th, they slowly grew smaller and began to recede although intense pain persisted. At this point my mouth sores had also diminished and were fading at a faster rate than the vulvar sores, with minimal disruption to function besides avoiding particularly sharp/spicy/salty foods. I kept up use of the topical numbing cream on the vulvar ulcers until April 26th, at which point most sores had healed and I was able to urinate and bathe in a normal manor, although I still needed to be gentle/the area still felt sensitive. At the time of writing this report (April 28th), I still see some redness/potential scarring but there are no longer open sores and there is no noticeable pain/sensitivity.
Per ER report, patient received his Flu vaccine at his 9 month well check. Parents took him home. He fed and then went down for a nap. One to two hours later mother reports finding the child cyanotic and unresponsive. EMS called and found him in asystole. EMS attempted resuscitation en route to ER by placing IO and attempted intubation. He was given epinephrine x 2. CPR continued in the ED. Warmed to 35.4, intubated with 3.5 cuffed ET and received multiple rounds of epinephrine. Chest compressions were recorded for 18 minutes. Time of death was called at 1814.
Mom advised this 3 year old female began having problems with cough, wheezing, upset stomach, diarrhea from 2012 months of age with multiple visits to MD to rule out sinus infections. Mom reported after her daughter receiving her 1 year old vaccinations 5/25/2011 (MMR #1 PREVNAR 13 #4), child developed diarrhea and red macular rash to vaginal area with swelling and was sent to allergy clinic (after moving from one place to another) where it was identified she had an egg, peanut, grass and tree nut allergy (positive skin prick test). Mom advised when they adjusted her diet/environment all her symptoms eased. At age 2, mom advised when child was given annual flu vaccine 10/25/2012 with 2nd flu shot (2 weeks later) her daughter again experienced vaginal swelling, rash and loose stool similar to reactions after 1 year old vaccinations what again lasted 2-4 days each. Mom described swelling was to external labia with the rash as red patchy bumps and diarrhea as loose watery brown stool. She treated with oral BENADRYL and used DENTIN like cream to rash with resolution of all symptoms. Child is 3 years old now and needs annual influenza vaccinations. Mom advised Dr, allergist advised this was not an IgE mediated event and it was okay for child to get flu vaccine. She is requesting a second opinion. Comprehensive review electronic medical records: 2/22/2011 she received influenza and hepatitis B vaccine (transcribed, unknown lot #s), with Varicella vaccine on 2/25/2011 (9 month of age). There was no reported adverse reaction or worsening of existing skin irritation (under care of allergist). July-December 2011 patient was seen twice for runny nose, watery eyes, diarrhea, diaper rash and initial evaluation for possible food allergies. Mom reports "hives" and facial swelling to diary products with vomiting after cow's milk, mac/cheese, regular cheese, and peanut butter. Diarrhea was described as watery brown diarrhea on and off for 6 months with rash to lower abdomen as slightly erythema papules to mins pubis region-diaper region. A comprehensive evaluation identified child was being given 100% whole juice greater than 30 ounces/day. By late November 2011 with reduction of fruit juices, her diarrhea and diaper dermatitis had completely resolved. 2011-2012 Skin prick testing was positive (x2) to egg, peanut, tree nuts, grass, ragweed, mold, cats and dogs. Strict avoidance of these items was recommended and an epi pen jr was provided. Oral challenge to whole cow's mils was negative and child tolerated yogurt products without vomiting. Mom advised may use dairy products. Her allergist advised on 6/28/2012 that egg allergies was not a contraindication to the MMR or flu vaccines however he recommended repeat skin testing prior to receipt of yellow fever or HPV vaccine in future. On 10/15/2012 child received annual flu shot (SP U4481BA - FLUZONE (?)) with mom reporting that night onset of diarrhea and vaginal swelling (labia) with red papular rash with diarrhea that lasted 2-3 days. Two weeks later she was reported to receive a second flu shot (no documentation of found) with similar symptoms. Mom treated with BENADRYL and topical creams.
Low grade fever (100 degrees); Chills; aches; fatigue; This is a spontaneous report from a contactable consumer reported for himself. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL3248), on right arm via an unspecified route of administration on 01Feb2021 13:15 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, (Lot no: EL3248) on 13Jan2021 01:15 pm for covid-19 immunisation. On 02Feb2021 12:00 AM patient experienced low grade fever (100 degrees), chills, aches and fatigue. Outcome of the events was recovered on unspecified date in 2021.
I felt really sick the following day! I had COVID-19 prior to this so it felt like that again... 48 hours after I had chest pain and shortness of breath! I went to the hospital and my blood pressure was 166 over 99... blood tests came back ok for now
Hives on my neck, arms, legs, chest, stomach, etc. they have been persisting since Friday evening. I took Benadryl last night and that helped with the itching but more seem to be appearing.
Extreme fussiness started evening of 4/5/16. Decreased appetite - no stool - seemed to be stomach pain. Seen in office 4/6/16 with normal exam except fussiness. Sent to ER 4/7/16 because fussiness continued. No fever - neg ultrasound of abdomen. Pain relievers no help - on ZANTAC for reflux.
gave a dose of quadracel to a patient who was too young with no reported adverse event; Initial information was received on 05-Oct-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (MI) (reference number- 00799016).  This case involves a 20 months old patient (unknown gender) who received a dose of 15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] who was reportedly too young (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "Nurse practitioner states they gave a dose of QUADRACEL to a patient who was too young according to the recommendations in the prescribing information."  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sore arm and shoulder; Sore arm and shoulder; Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (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 (Dose 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer: Unknown), for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset Oct2022, outcome "unknown" and all described as "Sore arm and shoulder"; LYMPHADENOPATHY (non-serious) with onset Oct2022, outcome "unknown", described as "Swollen lymph nodes". It was unknown if therapeutic measures were taken as a result of pain in extremity, arthralgia, lymphadenopathy.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Extreme fatigue from 3/11/21 to3/19/21; Severe headache from 3/12/21 to 3/18/21; light-headed sensation 3/12/21 to 3/20/21; fainted 3/17/21; gastrointestinal issues and severe cramping the evening of 3/15/21 to 3/17/21; gastrointestinal issues (constipation followed with diarrhea without cramping).Colo
Vaccine administered 6 hours after reconstitution...Contacted fpizer,CDC, ACIP and local epidemiologist Dr....Dr. advice was followed to consider dose give as valid and offer re-vaccination only if patient wanted.  Patient was contacted and expanded the issue offered advisement from Dr. and offered re-vaccination if wanted.  no adverse reaction s/p vaccination.
When patient woke up mom noticed that his face lips & mouth were swollen.  At the daycare they noticed that his right arm over the deltoid muscle, was a 6X7 cm area of redness & edema.  There was no cough, wheeze or hives. The daycare gave the patient 1 1/2 tsp Benadryl at 9:30 am & the facial swelling resolved, but the arm pain & swelling remained.  Patient was seen at the Dr.s office at 3:30 and found to have the above described symptom on the arm, but no facial edema, wheezing or cough.
pt rec;d grey cap pfizer vaccine after it was stored in freezer for 22 days- replacement dose given on 6/2/22
hospital employee did not achieve acceptable titer level p/3rd vax w/Hep B vax;
Vaccines given approximately 1400 3-12-12 - over following 6-8 hours infant had low grade fever and jerky movements of upper arms. Resolution & no residual problems.
No issue. No adverse event on patient.; Temeprature excurseion total time 25 min, 3 excursion. Escursion were not noted until after the fact due to employee error of cleanning data logger more than once a day; This spontaneous report has been received from an office manager, regarding a 13-years-old male patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-OCT-2022, the patient was vaccinated with one improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, as prophylaxis (lot number and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023, unspecified which one was administered to this patient) (Strength, dose, scheme, route and anatomical location of administration were not reported).  Temperature excursion total time was of 25 minutes, divided in 3 temperature excursions, one on 09-SEP-2022 for 8 minutes, one on 16-SEP-2022 for 5 minutes and another one on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines were purchased with public, and privet founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice. No additional adverse event was reported.  This is one of several reports received from the same reporter.
Sudden onset of red flushed face, burning sensation of face, red bloodshot eyes 30 hours post inhjection No other body part impacted. No fever, no other symptoms
Patient received J & J vaccine on 3/12/21. PCP states patient was admitted 4/21/21 with Pulmonary Embolism
Got the vaccine, and had no problems as she was busy in the house, cleaning.  Later during the day when she went to check a  note without her glasses was not able to see, which she was able to do before she got the vaccine.  She cannot read anything close up right now without looking through her bifocals, which she did not have any blurry vision before the vaccine.  She now cannot read anything far away without blurry vision, mainly distance reading, but again was able to do that before.  Before her vaccine she used glasses for close up reading only.  Her arm was sore for a day and a night and has no problems with the injection site itself.  She does have an appointment with an Ophthalmologist is tomorrow.
Softball sized swollen area, red and itchy.  Pt treated w/Orapred 15mg/5mL; 5mL qd x 5 days, OTC Benadryl qd prn.
Approximately 1hr after injection reported hives to posterior arm. Raised large whelps (6 or so) noted. Sent to facility for medical attention/evaluation given Dexamethasone 8mg IM.
patient reported swelling of the arm from shoulder to fingertips, pain of the arm and decreased mobility to the point that patient had to use the opposite arm to move it.  Swelling started the morning following the immunization.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant medication information was provided.  The reporter administered the vaccine to the patient after the 30 day by used.  Patient received half dose.  The vial was initially stored in refrigerator on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment drug details was reported.