chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; hives all over her body/welts/Multiple whelps; This is a spontaneous report from a contactable nurse (patient's mother). A 15-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16May2021 (at the age of 15-years-old) (Lot Number: EW0161) as single dose for covid-19 immunisation.  Medical history included mensuration cramps. Concomitant medications included ibuprofen (MOTRIN) taken for mensuration cramps; paracetamol (TYLENOL) taken for mensuration cramps; ibuprofen taken for mensuration cramps. She was taking Motrin and Tylenol. Motrin was 200mg and she was taking, she didn't start Motrin until Wednesday, that would have been 18th and in 24hr. On Tuesday she took 400mg Motrin for the whole day and Yesterday she took about a 1000mg of Motrin in the 24 hour period. So she took it may be 3 times, so each pill is 200mg. She had her period and she was getting mensuration cramps, so that's why she was taking it. It's a gel cap. The Tylenol she was taking, she took on Wednesday that would have been the 17th she was taking Tylenol, so she was taking about a 1000mg coz they are 550mg per tablet and she was taking two times, may be three times. The patient received first of the vaccine on 16May2021. Last night 19May2021 around 11pm she was very itchy with hives/welts but then went away. Then at 4am extremely itchy on thighs stomach back, and then again today on wrist as well on thighs, stomach and back, down to her knees. She had been taking Benadryl and Zyrtec. She also got her period on 16May2021 and had been taking mostly TYLENOL and some ibuprofen. She usually took MOTRIN during her period and had no problems. The nurse stated "My daughter took the Pfizer vaccine on Sunday, 16May2021 and last night 19May2021 she developed multiple whelps, hives all over her body, her abdomen, her legs, very itchy and it still continued on today. Now, she's 15, I have not taken her to doctor but I do plan to do that tomorrow but since you have a calling number for adverse reaction then I'm thinking this might be a delayed reaction to the vaccine, I'm not sure. Does that spell familiar?" Nurse stated "I have given her Benadryl and Zyrtec, only 25mg she got one last night that may be 5 in the morning and then she took another one about an hour ago 25mg. Two Benadryl 25 & 25 today and last night and she took one Zyrtec. The Benadryl is in 25mg tablet orally. She took Zyrtec now, she took one its 10mg oral." The outcome of the events was not recovered. For Causality, Nurse stated, "That's what I'm thinking. She has not taken anything out of the normal, that the only thing I can think of. It could be."
While technician finished administering the vaccine , patient had seizure like reaction that lasted for about 15 seconds . Patient immediately gained consciousness and had no recollection of what happened. He waited for 30 minutes and totally fine. Prior to giving the shot, patient checked  the box for feeling dizzy after vaccinations, when I inquired about it , he said that was years back and he had no issues with any vaccines that he has taken. He take flu vaccine every year.
screaming w/APAP for 3 hrs MD ordered more APAP - 101 temp; consoled crying w/final dose of APAP; has head cold today;
This case was reported by a consumer via call center representative and described the occurrence of feeling hot in a 53-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 22nd May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 23rd May 2018, 1 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced feeling hot, fever and nausea. On an unknown date, the patient experienced incomplete course of vaccination. On 27th May 2018, the outcome of the feeling hot, fever and nausea were recovered/resolved. On an unknown date, the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the feeling hot, fever and nausea to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on right deltoid. The patient states he received his 1st dose at about 8:30 at night. The patient stated the next day he felt hot at work and left early. The patient noted he had a fever and felt nauseous. The patient did not go to work on next day due to the symptoms, he stayed home in bed. On Friday the patient worked from home, was doing better. The patient stated he was still slightly nauseous on Saturday but everything resolved by Sunday. The patient also noted he had not been able to get his 2nd dose and was beyond the 6 month window, which led to incomplete course of vaccination.
No ADR at this time but I adminstered an additional flu vaccine inadvertantly.  Patient was there with her 2 six year old twin daughters. They were getting flu vaccines and she was getting a Hep A vaccine.  The syringes were mixed in the baskets and she received a flu vaccine first.  I notified the patient of the error and administered the correct vaccine.  The concern is that she had a flu vaccine already, on 11/20/2021.
From initial information received on 11/26/2002, it was reported that a 2 month old female infant received ACTHIB, Lot # UA666AA, intra-muscularly in the right thigh, IPOL, Lot # 16452, intra-muscularly in the left thigh, TRIPEDIA, Lot # U0582AA, intra-muscularly in the right thigh and HEPATITIS B VACCINE (Merck manufacturer), Lot # 0513M, intra-muscularly in the left thigh on 11/14/2002.  All vaccinations were given as initial doses.  ON an unspecified date and time, the patient experienced inconsolable crying, redness and puffiness.  The patient recovered.  The case is closed.  Linked to cases: U2002-01099, U2002-01115, U2002-01117 & U2002-01138.  From faxed correspondence received at AP, Inc. on 12/17/2002, it was reported that the patient received the vaccinations at 11:30 AM on 11/14/2002.  The adverse reactions occurred on the same day.  This case is closed.
SIDS death;no report of suspected vaccine assoc made by parents or MD;death certificate is attached;
10/29/18 AFTER CHILD RECEIVED VACCINES MOM STATED CHILD HAD TO BE RUSHED TO ER THAT EVENING AND AGAIN 10/31 WEDNESDAY FOR RASH ON ARMS, STOMACH, FACE, BACK AND LEGS, FEVER 104.7. AND CRIED FOR 3 HOURS AND WOULD NOT STOP. PER MOM ON 11/1 THURSDAY.
I would say within a week or two after I got the third vaccine, I started experiencing body aches and joint pain. I couldn't lay or sit in one position for very long and that's still occurring. I have treated it with Tylenol and occasionally once or twice I used ibuprofen. Recently, I went to a health fit store and got a different multivitamin and some tablets that have protein (complete protein). Also, the pain that I have, I've been taking Arnica tablets 150mg, which is temporary relief for joint pain, back pain, etc. Homeopathic started a week ago. I'm intending to see an orthopedist and if that doesn't help, I'll see my regular physician.
Information has been received from a registered nurse (R.N.) concerning a child (gender not specified) in elementary school (who is between grades 3-5) who was vaccinate with a dose of varicella virus vaccine live (Oka/Merck). It was reported that an outbreak of chickenpox began in an elementary school in November 2005. "Recently", "since November 2005", the child developed chickenpox and sought unspecified medical attention. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
little cough; Sore arm; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), COUGH (little cough) and MYALGIA (Sore arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced COUGH (little cough) and MYALGIA (Sore arm). At the time of the report, COVID-19 (COVID-19), COUGH (little cough) and MYALGIA (Sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information provided.   This case was linked to MOD-2021-114477 (Patient Link).
This 26 year-old male with a medical history significant only for gastroesophageal reflux disease and Helicobacter pylori gastritis developed cough, fever, and malaise 12 days prior to admission.  Home testing for COVID-19 was positive at this time.   Over the next several days, symptomatic improvement was noted.  On day 8, cough and dyspnea recurred, prompting him to seek treatment in the Emergency Department.  He received nebulized bronchodilator treatment and, with improvement, was discharged home.  On the day of admission, he again presented to the ED with worsened cough, fever, dyspnea, and shortness of breath requiring supplemental oxygen at 3 L/min to maintain adequate O2 saturation.  At this time, PCR testing was negative for influenza A/B and other respiratory pathogens but positive for SARS-CoV-2.   He was admitted to hospital and received treatment with antitussives, histamine H2 receptor antagonist, thromboprophylaxis, dexamethasone 6 mg daily, and remdesivir 200 mg IV followed by 100 mg daily for an anticipated 4-day course.  Clinical improvement is noted and planning is underway for comprehensive follow-up care management once he is deemed medically stable.
0700 when I awoke there was a swollen & raised red bump ~ 3.5" in length on back of arm @ injection site.  Immense pain upon flexion of arm, and a dull pain at rest. Began itching about 1400.   By 1900 the site had reduced to ~ 2" in diameter. 1700 on 7-Feb-2011 the size of irritation is about 1" in diameter, still red and swollen and itching like crazy.
Patient reports that for 4 days after recieving her covid vaccine she had dizzy spells that would last for 5-10 minutes. Patient also reports that a week after getting her covid vaccine she had a red raised lump on her arm farther down than where the vaccine was injected. She states the redness and raised lump was about 5inchesX6inches. Site was also itchy.  She is feeling fine as of phone conversation with her on last week
Patient felt fine during the 15 minute observation period. While driving home from getting the vaccine, she felt flushed on her neck and through her sinuses. After a couple of hours she experienced a tingling sensation on her tongue. She had no swelling of her tongue. The following morning following her vaccination, she felt a burning sensation on her tongue that last the whole day. The following day (day 2 post vaccination), the patient said her burning tongue sensation was gone but her eyes and nose were burning and irritated. On day 4 post vaccination, she also experienced shivering. She recovered from these adverse events on day 5 post vaccination but later got a sinus infection and subsequent yeast infection about 1-2 weeks later after she received her Remicade. She is going to delay her second dose vaccination until she recovers.
Information has been received from a registered pharmacist concerning a 61 year-old male patient with an allergy to tetanus toxoids and history of respiratory problems. On 08-SEP-2011, the patient was vaccinated with ZOSTAVAX (Merck) (lot # 670542/0619AA; expiration 26-JUL-2012), 0.65 ml, subcutaneously (LPLA). No other vaccines were administered at the time of the ZOSTAVAX (Merck). Post injection, the patient developed Bells Palsy. The patient's physician was notified. Additional information has been requested.
Pt was given Pfizer Covid Bivalent (5-11yr) without being diluted
Headache, Myalgia, Arthralgia, Diarrhea, fatigue Narrative:
Pfizer 4/7/21, 4/28/21, 12/14/21. Positive on 7/8/22
Headache, chills, severe fatigue, diarrhea, abdominal cramps,  pain at site, muscle soreness especially neck
3/2/21 became SOB, treated with oxygen and head of bed up in bed, only at dessert and drank supplement, for evening meal, no pain noted.  3/3/21 staff helped get her up in morning, went to weight room to take her weight, she then appeared to be struggling to breath, she was brough back to her room and the aides summoned nurse for assessment, was put back into bed, nurse noted poor color and shallow breathing, resident passed away shortly after that.
This case was reported by a nurse and described the occurrence of therapeutic response decreased in a 4-year-old female patient who received DTaP vaccine. Co-suspect products included DTaP vaccine, DTaP vaccine and DTaP vaccine. On an unknown date, the patient received the 1st dose of DTaP vaccine, the 2nd dose of DTaP vaccine, the 3rd dose of DTaP vaccine and the 4th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, DTaP vaccine, DTaP vaccine and DTaP vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to DTaP vaccine, DTaP vaccine, DTaP vaccine and DTaP vaccine. Additional details were provided as follows: The case was reported by the Medical Assistant. The age at vaccination was not reported. The reporter reported that a 4 year old patient who received her 4th dose of DTaP (batch number and expiry date unknown) and underwent unspecified test and results showed low titer levels, this led to therapeutic response decreased. No other clarifying information provided. No other information provided.
Information has been received from a nurse, concerning a male patient of an unknown age.  The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 06-JUL-2017, the patient was vaccinated with an unspecified expired dose of GARDASIL 9 lot number: L044475 with expiration date of 12-MAY-2017 (dose, dose number, anatomical location and route of administration were not provided) for prophylaxis. No adverse effects were reported.
Pt received IM dose of FLUVIRIN 2009-2010 at 10:16. Reported back to pharmacist after 15 minutes that throat felt tight, could breathe but didn't feel like he could take a really deep breath. Offered to monitor further but pt declined. Went to walk-in clinic. Called pt at 16:30 for follow up and he said he was fine.
A  hive at the injection site, 2 smaller hives adjacent, and some itching . . . s/p 7 days after vaccination.
Fever as high as 102.3 for 48 hrs, lowered with Tylenol.  Heart racing with fever.  Fever broke, then had a red rash on my chest, part of neck and near arm pits.  Not itchy or hot.  Rash never spead down trunk or onto back or arms or legs.  Rash resolved after 24 hrs, did take Benadryl.  Did not seek medical attention.
I received the Tdap vaccine but unsure what type/brand. When I left the office after the injection I could feel a tingly pain going down my arm into my hand. By that evening it was painful to lift my arm up past shoulder height. By Friday morning I had so much pain I could not get dressed without breaking down in tears. It was just not a sore shoulder it was severe pain. It was a pain that I connect with an injury not an injection. I called the doctor's office Friday morning and was advised to use moist heat and ibuprofen, if no relief to make an appointment Monday morning. As of today I still have pain. I have also missed 2 days if work because of thus pain.
Not sure what kind. Inactivated Quadrivalent Influenza Vaccine. Severe pain in shoulder and where shot was given and difficulty moving the arm.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a seven-year-old male. Neither relevant medical history now concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010, On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Patient called reported feeling horrible worse than when had the flu with headache and dizziness that cause fall.
Information has been received from a pharmacist concerning an 83 year old male who on 15-FEB-2007 was vaccinated SC with the "usual dose" of Zostavax. Subsequently "may have possibly broke out in shingles". As of 20-FEB-2007, the patient was in the process of seeing the physician in order to confirm a diagnosis of shingles. There was no product quality complaint involved. Additional information has been requested.
Meningococcal and GARDASIL HPV vaccines were given on 5/6/13 both in right arm. Went to Urgent Care next day with red swollen 1/2 right upper arm and warm to touch. Received at UC clindamycin. Came into office today 5-8-13. Still red, warm, and swollen.
Deltoid erythema and warmth with extension toward axilla. Started about 24 hours after shot. + chills/sweats, sore arm. Possible cellulitis versus shot reaction->rx for cephalexin given if spreads further. Had pneumonia 3 weeks prior.
One week after in Vaccine injection, the injection site became sore, red and swelling with a ?tingling sensation? in my left hand.  While the soreness, redness and swelling are  persistent, the tingling sensation comes and goes.
Moderna vaccine was given at external location.  Patient had documented unprovoked pulmonary embolus, documented with hospital stay June 19, 2021. He had no risk factors for clot.
Swollen lymph node under collar bone (clavicle); This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (medical history not reported).   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)). At the time of the report, LYMPHADENOPATHY (Swollen lymph node under collar bone (clavicle)) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
3 DAYS AFTER VACCINATION HER RIGHT ARM DEVELOPED RED ITCHY RASH SPOTS WHICH THE LARGEST WAS 3"X5". SHE ALSO COMPLAINED OF A FEVER THAT "BROKE" BY 9/21/18 AND INCREASED BP (174/93 PULSE 61 ON 9/21/18 AT 6PM).
Sjogren's; is pregnant/received her first two doses of the Pfizer BioNTech Covid 19 vaccine while pregnant.; This is a spontaneous report from a contactable consumer (mother) from the Pfizer-sponsored program. This consumer reported information for both mother and fetus/baby. This is a maternal report. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (age at vaccination was at 31 years old) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. Medical history was not reported. Concomitant medication included hydroxychloroquine (HYDROXYCHLOROQUINE) taken for an unspecified indication, start and stop date were not reported. The patient has Sjogren's and is pregnant and received her first two doses of the Pfizer BioNTech Covid 19 vaccine while pregnant. The event outcome was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
vial put into the refrigerator 11/01/2021. used beyond 31 days.
Rash developed 9-11 days after receiving moderna booster. It appears to be dermatographia. I have treated it with antihistamines but continue to have itchiness and redness. The condition is still present. I plan to go to a primary care physician or dermatologist soon.
Patient reported that there was redness and soreness at the arm where the shot was administered on 12/15/19.  She went to the doctor to be evaluated on 12/18/19 by dr. who discussed  a case of cellulitis of her left upper extremity rather than an allergic reaction to the shingrix shot. The  pt was given a antibiotics which cleared up the area.
Pfizer COVID-19 vaccine was administered to patient by pharmacist on 9/30/21. Approximately 10 minutes after the vaccine, pharmacist was alerted by the patient's co-worker that the patient was exhibiting signs of fainting. Pharmacist called emergency services according to standard operating procedures and when patient actually fainted, ammonia inhalant was used to awaken patient. An ice pack was used while emergency services arrived, and patient was released according to EMS suggestion and patient consent to decline hospital transport.
While administering vaccine dose to patient with parent in room, patient tensed up arm and moved away from Pharmacist which resulted in no vaccine being given to patient and a lost dose. New dose was readministered to patient because Pharmacist did not begin to administer vaccine before syringe was withdrawn from patient's arm.
had a reaction to the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (had a reaction to the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
About 2 hours following the administration of the immunization, pain, redness, rash, and swelling began. Pain is now so intense, that I am unable to move my arm.