chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye puffiness; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced eye puffiness on an unspecified date. It was further reported that the patient started using a facial cream around the same time and developed eye puffiness. She discontinued the cream but her eyes are still puffy. The outcome of the event was unknown.  Information on Lot/Batch has been requested.
No symptoms, patient was given a vaccine through the age of 42 month till 6 years old when patient is 12 years old.
symptoms included headache and severe cramping and diarrhea for 18 hours and then lack of appetite for 2 days.
Following immunizations, child developed facial rash that extended to neck and chest and some bilateral lower extremity involvement within 15 minutes of getting vaccines.  Child very fussy.  Given Benadryl and rash resolved but returned within 30 minutes.  Child sick with afebrile uri at time of vaccination.  Child had some wheezing during visit as well. 3/30/07 Received medical records from hospital which reveal patient experienced a 1 week history of bronchiolitis w/home nebs.  Seen on 12/28/06 by PCP for recheck & was given vax.  Within 15 min developed rash & had respiratory distress.  Received Benadryl in office which he vomited & dose repeated along w/oral steroids & neb treatment.  Had low grade fever & runny nose.  Afebrile on admission, O2 sat was 100% on RA.  Lungs had occasional rhonchi & wheeze.  Rash had resolved prior to ER.  Admitted overnight for continued observation.  Progressed well w/some emesis overnight & small rash noted on cheeks.  D/C to home next day on continued oral steroids & nebs. FINAL DX: Allergic reaction; resolving bronchiolitis; & resolving thrush.
Raised, red swelling at injection site that is firm and warm to the touch. Slightly itchy and slightly painful.
Extreme muscle fatigue and joint pain started 9 hours after vaccination. The muscle and joint pain never went away. I have now been vaccinated for over 2 months and still have debilitating muscle pain everyday.
This is a spontaneous report received from a contactable consumer or other non HCP (consumer reported for her Husband). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number and Expiration date: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization (Reason for no lot number: of COVID-19 Shot: Caller unwilling to complete the report). The patient medical history and concomitant medications were not reported. Reporter confirmed it was the COVID-19 shot from Pfizer. The reporter stated that her husband and I both have shot around noon on Monday and last night he experienced and this morning when he got up experienced dizziness and he was over of it now and seems to be fine. The patient experienced dizziness on an unspecified date. Reporter stated, That would be a side effect, her husband was dizzy during the night and that's the only side effect he has had and the reporter just thought is that important that for Pfizer to know that. Reporter was informed about the Pfizer Medical Information and provided with the number. Further probing was not done as reporter was unwilling to share further information. Hence, limited information available over the call. The clinical outcome of the event dizziness was unknown. Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
COVID symptoms; extreme fatigue; headache; feverish; She would get hot and then very cold; This is a spontaneous report from a contactable consumer patient. A female patient of an unspecified age (reported as late 60's to early 70's) received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Hours later after received the vaccine, the patient experienced COVID symptoms. She felt extreme fatigue, headache and felt feverish but never took her temperature. She would get hot and then very cold. The outcome of events was unknown.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
From the clients email message: "I thought I should make someone aware that I had an issue from getting the flu shot on 11/3/14. Tuesday 11/4 evening I noticed that about 3 inches below the injection site there was a large 4"x3" raised red welt. The next morning I called the Nurses line on our insurance card and she said to call my doctor right away. I did that and saw Dr at 9:30 Wednesday 11/5. He diagnosed this as an infection directly related to the break in the skin from the injection. When I got the flu shot the nurse did use a newly packaged needle but when I had a drop of blood at the site she reached quickly and grabbed a piece of gauze to wipe it then opened a band aid and covered the site. I do not think the piece gauze was newly opened. Also no alcohol was wiped on the area after it bled. Dr placed me on a 7 day antibiotic. The infection had gotten into the small lymph nodes under my arm but not in the larger ones under the arm pit although it would have quickly done so if I had not gone to the doctor. He ordered me home for 2 days with my arm elevated and iced for the swelling. This was not a pleasant experience and those lymph nodes were very uncomfortable. I am letting you know so that someone can be aware and look into their sanitary practice."
Passed away 4 days after second dose, complained of not being able to breathe in the middle of the night, and passed minutes later.
Information regarding PREVNAR was received from a consumer regarding a female patient who experienced mild redness on the injection site.  The patient received a dose on an unspecified date.  The patient experienced mild redness on the injection site.  The outcome was not specified.  No additional information was available at the time of this report.
Case number PHEH2014US021653 is an initial spontaneous report received from a health care professional (receptionist) on 24 OCT 2014. This report refers to a 54 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) subcutaneously on an unknown date (reported as 2 weeks ago). No adverse events were reported following the maladministration.
Two weeks after shot, patient reported severe head and neck pain resulting in ER visit.  He underwent CAT scan , received pain meds for one week.  Patient followed up with primary 5/3-recieved nasal spray.  On 5/7, ER visit -head/neck pain-CT scan, xray, medication given-nothing found on tests.  On 5/17, ER visit due to left eye lid unable to close and lip twitching-Xray and CAT scan diagnosed with Belle's Palsy, which has since resolved but patient continues to be in pain.  Following up with neurologist in future
VARIVAX was administered after undergoing a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 15-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen was not reported), lot # T035400 and expiration date 16-OCT-2022 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 0.4 degree celsius (°C) for 13 hours and 10 minutes on an unspecified date); no previous temperature excursions were reported.   The call was made due to a digital data logger.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2107USA006957: US-009507513-2107USA006887: US-009507513-2107USA007004: US-009507513-2107USA007007: US-009507513-2107USA007009:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 27-MAY-2015, the patient was vaccinated with a dose of VARIVAX (Merck) (0.5 ml, subcutaneous, lot # J004161, expiration date 05-APR-2015), after the expiration date. Concomitant medication was not provided. No adverse events were reported. The patient did not seek medical attention. Additional information has been requested.
Swollen Red spot / on his left arm; felt punky for seven to ten days or Malaise; Low grade fever; Swollen Red spot / on his left arm; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities. On an unknown date, the outcome of the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling unwell, low grade fever and erythema of extremities to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. One time user of Shingrix reported swollen red spot that measured approximately six inches on his left arm where received the injection.  The patient reported low grade Fever. And felt punky for seven to ten days or malaise.  The reporter did not consent to follow up.
Patient developed swelling and redness after getting the pneumonia and flu shot in the same arm, about the size of an apple. The swelling and reddness was there for about 1.5 weeks untill the patient got prednisone. One day after recieving the shots, the patient developed severe chills and fever for 2 days.
Allergic reaction; Pain in left arm at injection site; This is a spontaneous case from reported by a physician to agency (reference number: SEQ19-02156), initially received on 29-Aug-2019 and processed together with follow up received on 30-Aug-2019, concerning a 62-year-old, adult female patient.  The patient's medical history included: allergy to vancomycin, allergic reaction due to administered Flucelvax vaccine last year and possible egg allergy. The patient concomitant medications included: simvastatin, Ventolin (salbutamol), Symbicort (budesonide, formoterole fumarate), losartan, hydrochlorothiazide, amlodipine, Anapril (enalapril maleate) and Lasix (furosemide).   On 27-Aug-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, batch number: 261208, expiration date: Jun-2020, route of administration, anatomical location: not reported] for influenza prophylaxis.  On 28-Aug-2019, 1 day after vaccination, the patient developed allergic reaction, with symptoms of redness, swelling and itching. The patient also experienced pain in left arm at injection site. Since it was reported that for 2019 and 2020, all 4 vaccine strains for Flucelvax would be cell derived and therefore Flucelvax would not contain any egg protein, egg allergy was excluded as cause for the allergic reaction. The patient was treated with Tylenol (paracetamol), Medrol dose pack (methylprednisolone) and Vistaril (hydroxyzine hydrochloride) for the events.  The outcome of the events was not reported and it was confirmed that no further information would be provided.  The reporter assessed the case as non-serious and did not provide causality assessment to Flucelvax.  Non-significant follow up received by the physician on 10-Sep-2019: It was reported that the physician had no further information to provide regarding outcomes of the events. Narrative was amended accordingly.  Company comment: All events are considered related to Flucelvax.; Reporter's Comments: All events are considered related to Flucelvax.
After Covid 19 vaccine (Moderna) administration (1st dose), the patient felt light headed and nauseated. She could not stand up right after the shot and needed to rest for a while until the paramedic came and brought her to the ambulance for observation.
Initial information received on 08-Oct-2018 regarding an unsolicited valid serious case received from a other health professional. This case is linked to case 2018SA280098 (same reporter). This case involves Elderly female patient (age not reported), who developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot: UJ004AB and expiry date: 30-Mar-2019) via intramuscular route in the left deltoid. On an unspecified date, the patient developed a serious band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis (cellulitis) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. It was reported that patient was seen by the nurse practitioner on 05-Oct-2018. No Lab data was reported. Final diagnosis was developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis. The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN) on an unknown date. The patient outcome is reported as Unknown for developed band like around lateral side of her arm 1-2 inches below the injection site and diagnosed with cellulitis. Documents held by the sender: none.; Sender's Comments: This case involves an elderly patient who presented with cellulitis after vaccination. Time to onset is not known. There is, moreover, no information regarding patient's medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.
First day: Pain in upper arm of injection site after about 2 hours; starting after about 4 hours: headache, fatigue, chills; after about 5 hours: right ear ache; after about 6 hours: nausea. Second day developed mild congestion and croupy cough.  Side effects improved after 3 days and lasted 5 days.
Patient presented 1 week after COVID with petechiae and purpura. She had platelet count <2,000 that has been refractory to ITP front line treatments including IVIG x 2, corticosteroids and romiplostim.
pt recv vax 21OCT95 & w/in a few hrs of vax pt devel flushing on both ears & the face,redness @ inj site;pt exp swollen lt ancillary & lt inguinal lymph nodes;addtl info recv 24JAN96;tx w/APAP & cool compresses
This case was reported by a pharmacist via out of hour services and described the occurrence of upset stomach in a 50-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received SHINGRIX. In August 2018, less than a month after receiving SHINGRIX, the patient experienced upset stomach, rash and skin warm. On an unknown date, the outcome of the upset stomach, rash and skin warm were not recovered/not resolved. It was unknown if the reporter considered the upset stomach, rash and skin warm to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the SHINGRIX vaccine was administered to a plus 50 year old woman about two weeks ago and she experienced an upset stomach and rash that subsided. Two weeks later, the rash had come back and it was very warm and she had an upset stomach again. The patient was a nurse and was very upset.
"Petechiae like" rash developed on right lower leg. Rash resolved spontaneously over 72 hours with no treatment.
Left arm red, warm to touch , moves hands well, Cellulitis, Keflex 250/5 (1/2 tsp ) TID X 10 days.
Pt presented to ED at apx 1pm on 5/28/21 with signs of anaphylaxis. Swollen upper and lower lips, sensation of swollen throat, and facial swelling, with urticarial lesions to upper chest wall and arms. No GI symptoms. No hypotension. Received 0.3mg IM epinephrine, 50mg IV benadryl, 125mg IV solumedrol, and 20mg IV pepcid. Symptoms slowly resolved over 3-4 hours. Pt could not recall any other now inciting event or product other than vaccine she had yesterday around 4pm. No reaction to first pfizer vaccine noted.
The next night I started getting tingliness in my toes and upper feet. My legs were chill and my legs, thighs, and my face and my whole body was just chill and felt numb and I was fatigue, diarrhea, and nauseous. My head and my body just hurt all the time I lost 7 pounds in a week. My whole body just felt out of place. I had to contact the doctor a couple of times and the doctor some tests on me. I had sensation in my body which was unbearable.
After taking the second dose of the vaccine, I experienced serious side affects. I experienced headaches, fever and chills. I also had a serious rashes all over my body, causing itching and large bumps.
8:30 am the day after the vaccine my lower right lip and lower right face swelled.  For 14 days every day I had a headache and cramps.  Daily fatigue.  One day it felt like a giant hand was squeezing me around the chest and back.  Random periods of nausea.  One day I had overwhelming fatigue, it took every ounce of my strength to lift myself.  It felt like something was laying on me pushing me down.  Another day my upper  right lip and upper right face swelled. Arm hurt at vaccine site.  All this went on over a period of 2 weeks.  To this day my upper right lip randomly swells.
Information has been received from a physician concerning a 26 year old caucasian female who was vaccinated on 30-MAY-2007 with the first dose of GARDISIL IM (lot # 657868/0523U). Subsquently in June 2007 the patient experienced increased tenderness and pain in her breasts, chest achiness, and increased pain with her menstrual cycle. It occured after both her first and second doses. It was more pronounced the first couple days and lowered after that but she still feels some tenderness. The patient's increased tenderness in her breasts persisted. The patient sought unspecified medical attnetion. Patient does not want to continue the series. As of 11-OCT-2007 the patient still has symptoms. Additional information has been requested.
PATIENT WAS GIVEN A PFIZER COVID VACCINE THAT WAS NOT MIXED WITH THE DILUENT. .2ML WAS DRAWN UP AND GIVEN TO PATIENT WHO THEN WAITED THEIR 15MINUTES TIME WITH NO ADVERSE EFFECT.
Information has been received from an office staff at the doctor's office concerning an approximately 15 year old female who on 13-AUG-2008 was vaccinated with her third dose of GARDASIL (lot #659964/1978U).  On 10-SEP-2008 the patient came in the office with injection site inflammation with a lump at the site and swelling.  The patient had no adverse symptoms from the first and second dosed.  At the time of this report, the events persisted.  Additional information has been requested.
pt sent to ED from a walk in clinic for low O2 saturation; increasing SOB, productive cough, headache, neck pain; O2 supplementation; positive for COVID; given Dexamethasone and Remdesivir; pt slowly worsening; DNR; family wanted to take pt home; she passed away at home
Multiple menses per month; Excessive bleeding; Anemia; This is a spontaneous report from a contactable consumer, the patient. A 37-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 left arm on an unknown date in Feb2021 at 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. 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 vaccination. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) and lansoprazole (MANUFACTURER UNKNOWN) for unknown indication from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Jan2021 at 15:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. On 04Mar2021 at 13:00, the patient experienced multiple menses per month, excessive bleeding and anemia diagnosis (Dx). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 16Feb2021, the patient underwent COVID test (navica test) via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events.  The clinical outcome of the events multiple menses per month, excessive bleeding and anemia were resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
My vision is blurred and affecting me in my daily routine I feel light headed with slight migraine , my vision starts to get blurred on and off since getting my second vaccine not sure why I?m getting this type of reaction and wondering if this is a common side affect from Moderna
I had a postnasal drip, no fever, sweat or chill. I did have a cough, productive cough and the mucus started turning colors. I was taking Singulair and Keflex, once I lost my sense of smell, I tested for COVID-19. The test came back positive, I started on the Paxlovid and felt better within 24 hours except feeling tired after doing extreme mental work.
Extreme fatigue, weakness, myalgias, drowsiness, night sweats, abd pain, bloating, GERD, joint pain,