chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Porphyria Attack; she is still not feeling that well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Porphyria" (ongoing), notes: Porphyria; "respiratory failure" (unspecified if ongoing), notes: She states she has been in respiratory failure. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: PORPHYRIA (medically significant), outcome "unknown", described as "Porphyria Attack"; MALAISE (non-serious), outcome "not recovered", described as "she is still not feeling that well". 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.
Arm quite sore after few hours of receiving vaccine with soreness moving into armpit. Swollen in armpit, itchy and sore until Sunday evening (02/06/05) then it started feeling much better 02/07/05. Arm feels fine and armpit still a little tender, but much better. Vaccine given with Dr. prescription.
8 days later red circle around the site of the shot. Minor puffiness. Looked better next morning
Within a couple of minutes of vaccination, pt got dizzy, lightheaded and sweaty. She described her chest hurting  and compared it to having a hard time breathing when it's really cold out. Pt was also pale. She also reported "prickly" feeling in her fingers.  Moved patient from a sitting to a laying down position and gave her some orange juice. Pt started feeling better after laying down for about 5 minutes. Pt and her mom did not want us to call 911. Pt was back to feeling well in about 20 minutes post-vaccination and was able to walk out of the pharmacy. Pt and mom attributed it to not eating and being anxious about getting the vaccine.  Checked in with mom about 4 hours post-vaccination. Mom said pt had eaten and taken a nap and was feeling well and back to normal.
Information has been received from a consumer who is a 33 year old female physician with migraines, headaches and no known drug allergies who in 1998 was vaccinated with a first and second dose of varicella virus vaccine live. Concomitant therapy included verapamil HC1 for headaches. Subsequently, she was exposed to varicella and in 2001 had a titer drawn that was 0.  She reported that she was again exposed to varicella but was pregnant and received VZIG in 2002.  On 05/11/03 she was exposed to an adult with severe varicella. Unspecified medical attention was sought. No product quality complaint was noted. Additional information has been requested.
mild flu-like symptoms; Diffuse myalgias, more severe on both right and left arm; Numbness in lower legs evening of vaccine; Felt mild headache; foggy feeling this night; This is a spontaneous report from a contactable healthcare professional, reporting for a patient. A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number EK9231), intramuscular in the right arm on 30Dec2020 at 09:45 (at the age of 26-years-old) as a single dose for Covid-19 vaccination. Medical history included Covid-19 prior to the vaccination on an unknown date. The patient was not pregnant at the time of vaccination. The patient was not tested for COVID-19 post vaccination. The patient's concomitant medications were not reported. On 30Dec2020 at 19:30, the patient experienced diffuse myalgias, more severe on both right and left arm and numbness in lower legs the evening of the vaccine; felt mild headache and foggy feeling that night as well. The second day on 31Dec2020, the patient experienced mild flu-like symptoms such as weakness, fatigue, and myalgias. Therapeutic measures were taken for the myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness which included Tylenol. The clinical outcome of the events myalgia, hypoaesthesia, headache, feeling abnormal and influenza like illness was recovered on an unknown date.
had bad case of flu within days of getting flu shot; Initial information received on 30-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case is linked to case 2020SA346205.  This case involves patient (unknown demographics) reported had bad case of flu within days of getting flu shot (influenza) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had bad case of flu within days of getting flu shot (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
breakthrough covid-19; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (breakthrough covid-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAKTHROUGH COVID-19 (breakthrough covid-19). At the time of the report, BREAKTHROUGH COVID-19 (breakthrough covid-19) outcome was unknown.            No concomitant medications were reported.   No treatment medication was provided.  It had been reported that, the patient was fully vaccinated but unclear how many doses patient had received.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a patient of unknown age and gender with medical history reported as immunocompromised, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. The reported medical history of being immunocompromised is a confounder. Information regarding vaccine schedule, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with medical history reported as immunocompromised, who experienced the adverse event of special interest of breakthrough COVID-19 an unknown time after a dose of mRNA-1273. The reported medical history of being immunocompromised is a confounder. Information regarding vaccine schedule, clinical evaluation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
The shot was administered in my left arm.  I experienced localized swelling and axillary lymph node tenderness immediately after injection under my left armpit.  The right side of my face also became numb for about 5 minutes.  The next morning the areas around my eyes were swollen and I had two styes in my right eye.  I do not know if these were related.  These symptoms lasted approximately 3 days.  Some minimal swelling and tenderness seemed to remain, and approximately a week later I experienced a painful resurgence of the swelling at the injection site that was far larger, harder and more painful.  I took Benadryl and Ibuprofen.  These relieved the symptoms within 48 hours.
First night:excruciating headaches,pain in the neck,eyes hurt,stomach pain slight fever and chill so i took ibuprofen and that helped headaches and early sunday morning took aspirin also helped  Second day: all day muscle aches over body and very tired. Third day : my left arm that had vaccine hand and arm went numb for half hour an went away. Forth day:more than half day my vaccine arm and hand numb and try to shook it up but no luck and heard bad news about Janssen. I am very scared and worry about this vaccine about blood clot. they said it happened 6-13 days after vaccine shot. it's been only 5 days for me and i am very scared.
Mom phoned office 8-22-07 at 11:50 AM, stating pt. has large, hard, hot to touch area where Varivax was given.
Rash in circular motion, lack of appetite, lack of fluid intake, low fever (99-100) treatment TYLENOL, monitor, length of symptoms Tuesday -> Monday (6 days) symptoms started 24 hrs after given vaccine.
in the hospital for pneumonia; first dose on 22Mar2021 (no second dose); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (in the hospital for pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. WSY86RS56) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (in the hospital for pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (in the hospital for pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drug information provided. No concomitant drug information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Fatigue; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 25Apr2021 11:30 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 25Apr2021 07:00, outcome "recovered" (28Apr2021), described as "Fatigue"; HEADACHE (non-serious) with onset 25Apr2021 05:00, outcome "recovered" (01May2021), described as "Headache". Therapeutic measures were not taken as a result of fatigue, headache.  Additional information: Vaccination Facility Type: Pharmacy or drug store 2nd. Public Health Clinic/Administration Facility 1st. Vaccine Administered at Facility? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o bad HA that started at back of his head then through whole head, got very pale and nauseous and then vomited x 2. Pt c/o not feel god and nausea after too.
Child had blotchy skin on scalp after vaccine, no respiratory distress, swelling and redness at LAT injection sites.
became sleepy about 6PM about 8PM mom noticed rash all over body;temp ax 102 @ ER @ 1030PM-sent home sick (rash, inc temp) all weekend;saw MD 27JAN97;dx w/strep throat, ear infect & scarlet fever;started ATB x 10 days;no problems afterward
I was diagnosed with Transverse Spinal Myelitis at ER in town on April 27th. I had been suffering from sever back and neck pain for over a week. I reported to the ER due to the inability to void my bladder. I had full back, neck, and Brain MRI?s after being admitted to the hospital and neurologist Dr. made the diagnosis of Transverse Spinal Myelitis. I spent 3 days in the hospital and received 5 IV steroid treatments to treat my condition.
Pt received HIB and DTAP into left thigh. Erythematous macular lacy area 13cm X 13 cm surrounding injection site.
This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no  information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested.
Brief Notes: Patient initially was here for COVID vaccine Non-Provider visit.    Immediately, after vaccine she started having sweats, dyspnea and anxiety.    BP 138/100, hr 80, O2 97% CHEST: RRR without murmur LUNGS: CTA SKIN: No erythema, swelling.    EKG NSR with rate 73.    Pt had similar reaction after her first COVID vaccine. She went to ER after 2 days. Work up was negative. She was told this to be secondary to her Fibromyalgia.    Cold rags, water was provided.  Patient rested.  With observation, symptoms did improve.  She has mild headache, otherwise no chest pain, dyspnea, dizziness, nausea after 10 minutes.    Patient was observed for 30 minutes.  Did well with ambulation Discharged home with significant other Signs and symptoms to seek immediate medical attention discussed in detail.
On May 12th,  patient came for administration of first dose Pfizer vaccine. Documentation was reviewed. Medication was diluted with 1.3ml of sterile water. Medication was administered to patient. No reaction was reported during the 15 minutes of monitoring in clinic. After administration it was noted that medication was diluted with sterile water instead of 0.9% sodium chloride. Staff were notified immediately and Pfizer manufacturing was contacted. I spoke with staff from medication manufacturing at Pfizer, per Pfizer representative the effects of using sterile water as diluting agent have not been tested, and therefore cannot speak of the stability of the vaccine or its effect on patient. The only recommendation given was to discard doses diluted on sterile water. Afterwards, we communicated with Dr. According to Dr. and CDC recommendations, patient should be re-vaccinated immediately.  PNP was made aware of situation and notified of Dr. and CDC recommendations, PNP was also notified of vaccine manufacturing response. PNP and staff called patient to notify of situation, patient questions were answered. Patient was informed of CDC recommendation of re-vaccination, mother agreed to bring child back for re-vaccination on Saturday, May 21th.
This spontaneous report as received from a health care professional refers to unspecified number or patients of unknown age and gender. On unknown dates, between October 2014 and December 2014, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), dose 0.5 ml, subcutaneous, (lot number and expiration date not reported). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered pharmacist concerning a female patient who may had been vaccinated with MMR II in the past and the patient had negative titers to rubella. Additional information has been requested.
Rash on Left arm, near but not on injection site. Rash is  flat, red, appx 3"x 4"
Initial report was received on 18 and 25 October 2011 from a health care professional, who is also the patient's parent. A female patient (date of birth not reported) had received on 17 October 2011 a left arm injection of FLUZONE intradermal, lot number UT4163AA and five to ten minutes after injection, developed a red, painful knot that was approximately two inches. On 18 October 2011, the "knot was even larger approximately four to five inches and looks like cellulitis." According to the reporter, the patient's arm was red, swollen and painful from the site to almost the elbow. Treatments included ADVIL and ice to the area. No further information was available at the time of the report. The patient recovered on 25 October 2011. Documents held by sender: none.
Pt 1st noticed pain in (L) hip on 6/23/09 - then started with egg sized red area with heat - progressed to 11 X 5 cm area - upper: illiac crest - Pt presented to doctor on 6/30/09 for eval - erythromycin 250 mg with POTID with food for 7 days was Rx'd for cellulitis
PT GIVEN INJECTION ON 9/22/20  IN SAME ARM THEN PT  CALLED  AND  CAME IN ON 9/24/20  COMPLAINING OF SWELLING IN UNDERARM AND REDNESS AND SLIGHT HEAT TO AREA-NOTHING NOTED AT INJECTION SITES-PT STATED IT WAS GETTING BETTER AND IS CALLING MD IF NOT BETTER TOMORROW- ALSO ADVISED OF BENADRYL  TO TAKE  AND POSSIBLE COLD COMPRESS
racing heart, right shoulder pain, shortness of breath, strong heart beat as if going through my chest, headache, chest discomfort.,increased blood pressure,
P/O seizures - 3 days prior to vaccination. Seizures 24 hr post vaccination.
Patient completed his 20 minute observance without incident.  He then reported to the medic 2 hr after vaccine was given, c/o weakness, and inability to walk without assistance.   Vital signs remained normal for another 15 minutes.  He indicated he had a similar episode one year prior but did not seek care.  He refused medical evacuation or further evaluation and departed the area.
On Saturday 03/13/2021 the patient's mother contacted me.  Due to the patient having a mental disability, the mother described the event.  She stated the patient's arm became very red, swollen, hot, and painful the day after vaccination.  I asked if the patient was having any trouble breathing other signs of anaphylaxis to which the mother responded "no."  I instructed the mother to give the patient Benadryl and to use a cold compress to help with the reaction.  I also told the mother if the patient's condition worsened, showed signs of anaphylaxis, or didn't improve within 3 days to go to her doctor.  On Sunday 03/14/2021 the patient and her mother came to the store and the mother asked me to examine the patient's arm.  There was a noticeable rash 6 inches in diameter.  I felt the arm in comparison to the other arm but did not notice any hardening or warmth.  The mother stated the patient's arm seemed to be improving from the previous day, but that the arm was still red and painful.  At this time, I advised the mother to draw a line around the rash; if it got bigger, she needed to go to the hospital, but if it got smaller that was a good sign that the condition was improving.  I instructed the mother to continue giving the patient Benadryl and using a cold compress.  I also advised that the patient should still receive the second dose of the series, because this was not an anaphylactic reaction.  I also advised the patient to pre-medicate with Benadryl before the second dose.  I told the patient I was going to ollow up with them in a few days.
The patient was scheduled to receive a flu vaccination but was accidentally given a Covid 19 Pfizer shot instead. It was the patient's 4 th dose . They had received their booster previously because the patient is immunocompromised. As of today no adverse effects according to the mother of the patient.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Approximately 30 minutes after administration, patient reported some difficulty breathing and extreme lightedheadness. Breathing was shallow. Also reported swollen tongue, which led to slurred speech. Benadryl was immediately given and patient was monitored for an additional hour. At the end, patient reported she felt better and speech improved, but still lightheaded like she \"just had 2 glasses of wine.\"
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.  Our Vaccine Task Force, after speaking with CDC and PA DOH, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
45 min post vax, pt develops foaming mouth, stiffening, ashen color, not responsive for couple of seconds. Pt taken to ER.  Admitted for full sepsis work up and seizure work up. Tx w/ amipicillin.
Yellow skin, stomach ache & vomiting began 1 week after 1st & 2nd doses of Hep-B vaccine. She stayed yellow for a month after each, cleared in between.
Myalgia, Fever, chills Narrative:  Had to stay home from work and take medication
shaking, trembling; cyanosis about mouth & extremities; spiked fever 103.8;
Patient was fully vaccinated with pfizer covid vaccine. Received the doses on 3/22/21 and 4/12/21. Patient subsequently tested positive for covid infection on 8/16/21.
numbness and tingling in hands, hands also turned purple and cold. lasted about 6 hours. Later leg pain and swelling, superficial thrombophlebitis
Within 5 minutes very sleepy, 5-10 min nausea and fever with chills sweat. Loss of vision and dissy. Medical staff checked and found skin changed color and very low blood pressure. After 25 minutes symptoms started going away.
ON 11-06-06 AFTER RECEIVING VACCINE PT STOOD UP AND HAD C/O FEELING FLUSHED, EARS FLEW SHUT, FELT EXTREME SPASMS IN HER UPPER AND LOWER BACK, SEVERE WEAKNESS AND TASTED THE INJECTION.  MD ASSESSED PT. AND D/C HOME (F/U PRN).            ON 11-10-06 PT. PRESENTS WITH EXTREME BACK PAIN, CRAMPS IN HER LEG, AND WEAKNESS.
The patient's parent lied about the patient's age on the intake form. The pharmacy realized the patient had lied when we contacted Pharmacy where they received their first dose. The Pharmacy informed us that the patient was only 11 years old.
rash with the following pathology, steroid responsive, no other discernible reason for rash:  Final Pathologic Diagnosis  A.  Skin, right upper arm, punch biopsy:  -   Subacute spongiotic dermatitis, see comment.    Comment(s)  Microscopic sections show a spongiotic epidermis with overlying parakeratosis  and serum crust.  There is papillary dermal edema and a superficial perivascular  chronic inflammatory infiltrate that includes occasional eosinophils.  A PAS  stain is negative for fungal organisms.  The findings are consistent with a  spongiotic dermatitis such as atopic dermatitis, allergic contact dermatitis,  nummular dermatitis, or a spongiotic drug eruption.  Clinical correlation is  recommended.
6 hours after :  chills, fever, fatigue Chronic:  mild ongoing headache,  back muscle pain, torn muscle in right calf.
Dad reports redness,swelling and warmth to vaccine site the evening after administration.  Patient seen 2 days after administration Dr. notes area on left thigh with layer (8"x6") reddened, warm, indurated lesion with 2-3 cluster of vesicles in middle of area  The layer of which has burst with clear fluid.  No other skin lesions noted.