chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 1/7/2021 around 10am I had normal arm pain, my right arm started swelling, my skin turned really read, red hard rash, my face turned very red, pain on my shoulder & neck, and very bad headaches, my work send me o the emergency room, & also I had hard time seeing everything was very hard to see. I felt very nauseas I couldn't eat for the first couple of days, a lot of body aches & felt very fatigue. In the emergency room they prescribed me  Trimodal & Zofran. I had to miss 4 days of work it lasted about 7 days the first 4 days my symptoms were sever but by the 5th day it was getting better.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 2 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA002302, 1210USA006260, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Itching all over body- "feels like bugs are crawling on me"- various prescription creams, steroids, allergy medication, antihistamines. Shaking/jerking Parkinsons like spasms in arms and legs- steroids, ativan, xanax Confusion  Visited ER twice because symptoms were so severe that I could not walk. They ruled out stroke and cardiac arrest. I also went to Urgent Care because I was itching so bad and referred to a dermotologist. She diagnosed me with excoriated prurigo- a rare diagnosis.  The itching and jerking has affected my quality of life. I have to have full time caregivers to perform my activities of daily living.
Back Pain; Knee pain; psoriasis; Injection Site Bruising; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE BRUISING (Injection Site Bruising), BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On 29-May-2021 at 10:55 AM, the patient experienced INJECTION SITE BRUISING (Injection Site Bruising). On an unknown date, the patient experienced BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis). At the time of the report, INJECTION SITE BRUISING (Injection Site Bruising), BACK PAIN (Back Pain), ARTHRALGIA (Knee pain) and PSORIASIS (psoriasis) outcome was unknown.        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  were reported     Reporter did not allow further contact
REDNESS AND SWELLING 3CM BY 3CM AT SITE OF INJECTION  TREATED WITH MOTRIN BENEDRYL AND KEFLEX RECOMMENDED APPLY ICE PACK FOR SWELLING AND FOLLOW UP IN 3 DAYS FOR RECHECK.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma; "Cholesterol" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma; "Asthma" (unspecified if ongoing), notes: I have blood pressure meds, cholesterol and asthma. Concomitant medication(s) included: SINGULAIR; XOPENEX; CLARITINE; LINZESS and Steroid pills 20,20,20,10,10,10 mg within 2 weeks of vaccination. Past drug history included: Decongestants, reaction(s): "Known allergies: Decongestants". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial and follow up information has been received from a registered nurse regarding a 14 month old (previously reported as 15 month old) female patient, with no known drug allergies, who on 11/18/2002 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 642645/0527M).  At the same time, the patient received a first dose of varicella virus vaccine live (Lot # 642996/0458M), a third dose of poliovirus vaccine (IPOL)(Lot # U1645) and tuberculin purified protein derivative (PPD Tine Test).  The patient was not ill at the time of vaccination.  On 11/30/2002 the patient developed a rash.  The nurse practitioner saw the patient in the clinic on 12/02/2002 and it was reported that the rash was "viral type" and all over the patient's body, mostly on trunk and arms.  The patient was afebrile (96.0 degrees Fahrenheit) with a normal exam (pulse 100, respirations 16) except for the rash.  The nurse describes the rash as "red pustules" and "measles type".  The mother reported fever.  It was reported that the child was well, active and eating "OK".  The patient was to return to clinic as needed if the rash became itchy or worse.  Subsequently, the patient recovered from the rash.  The patient has had no adverse events following prior vaccinations.  Additional information is not expected.
On 09/25/2021 I had rash, hives, blistering on my pelvic area from left to right of my legs and rawness and blistering on the lips of my vagina. My body was freezing of and on. Headache, fatigue, runny nose and body aches. I started using Allegra Allergy Pills and put Aveeno Cream on the areas on 09/27/2021, did make the rawness and blistering go away after October 4, 2021.
chest pain; dizziness; slight fever; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302; Expiration Date: 19Jan2021), via an unspecified route of administration in right arm on an unspecified date (at the age of 79-year-old) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chest pain, dizziness, slight fever, and loss of appetite on an unspecified date, 8 days after vaccination. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
When Mom changed child's pajamas, she noticed several spots that appeared to be hives. Child scratched her belly. 10/19/11-Follow up-Child ok. At ER, told most likely not shot, given Benadryl.
pt started experiencing inc heart rate; dec BP, elevated temp & SOB the afternoon p/taking vax; seen by MD next day; hospitalized for observation overnoc & pt was d/c following day;
Chills; I have a little red rash on my left thigh area/ smooth red rash on my upper left thigh, down to the knee cap; it is just like redness and that does not hurt, it is not itchy or nothing; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 22Jan2021 07:30 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the vaccine on 22Jan2021, this past Friday morning and roughly between 7:30 and was doing fine with it except that the patient had a little bit of chills but nothing predominant on an unspecified date. The patient also experienced a little red rash on the left thigh area and it is not raised or anything, it is just like redness and that does not hurt, it is not itchy or nothing on an unspecified date. The rash was described as smooth red rash on the upper left thigh, down to the knee cap but it is not itchy or hurting or anything. The outcome of the events was unknown.  The information about the batch number has been requested.
p/ pt recv vax on 4/22 devel itching at the hairline. the following day devel 50 red dots in skin on chest & arms w/itching on chest, hairline & down arms. red dots did not fill in w/fluid nor did they crust over.
Day after vaccine she felt tired, today she woke up coughed up  blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200
Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; Start Date/Time: [Pfizer] 4May2021 03:00 PM/Start Date/Time: [Pfizer] 12Jul2021 04:30 PM; my entire body became flush; I was hot to the touch; felt very tired; headache; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received bnt162b2 (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided), via an unspecified route of administration in the right arm on 12Jul2021 04:30 (Age at vaccination: 37-years) as dose 2, single for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included latex allergy. Patient is allergic to latex but unaware of any other allergies. Patient concomitant medications included Subutex taken for unknown indication, start and stop date unknown. Historical vaccine included BNT162bs (BNT162B2; solution for injection, Batch/Lot number, Expiration date was not provided) on 04May2021 at 03:00 PM in arm left as dose 1, single for covid-19 immunization. On 12Jul2021, within seconds of receiving the second dose, patient stood up to exit the vaccine area and her entire body became flush, she was hot to the touch and then felt very tired and a headache. When she woke up after eight hours, most side effects were gone from the event, still experiencing extreme tiredness. Ae treatment: Self-treatment with Benadryl. The outcome of the events her entire body became flush, she was hot to the touch and then felt very tired and a headache was recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever, headache, chills, fatigue, 36 hrs Fatigue 48 hours Treatment Tylenol
2 weeks afterward: developed shingles, then recurred.  Rash, intermittent. Still persists.  Peripheral neuropathy.
According to pt, redness, swelling at injection site for at least 4 weeks. After 3 months, pt still feels knot at injection site. MD has been contacted today 4/2/2019 for this issue.
Varicella Information has been received from a physician and a licensed practical nurse (LPN) concerning a 26 month old white male with a penicillin allergy and no other medical history who on 02-SEP-2005 at 10:00 was vaccinated SC in the right arm with the first does of varicella virus vaccine live (Oka/Merck) (Lot #648936/0114R). There was no concomitant therapy or illness at the time of vaccination. It was reported that on 10-SEP-2005, the patient developed a fever. On12-SEP-2005 the patient developed a rash on his torso. The patient was seen by a physician who determined that the patient had atypical varicella resolved. There was no product quality complaint. Additional information is not expected. Body temp 09/10/05 fever.
PSORIASIS ON WRIST, SLEEVE, ELBOWS AND LEGS; TIREDNESS; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 01-AUG-2021 for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for psoriatic arthritis, and moderate to severe chronic plaque psoriasis. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis on wrist, sleeve, elbows and legs, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from tiredness, and had not recovered from psoriasis on wrist, sleeve, elbows and legs. This report was non-serious.
Information has been received from a consumer concerning her approximately 16 month old son who on an unspecified date was vaccinated with a dose of RECOMBIVAX HB (manufacturer unknown) and a dose of influenza virus vaccine (unspecified). Subsequently the patient developed a fever and seizure. On an unspecified date the patient recovered from fever and seizure. Upon internal review, seizure was determined to be an other important medical event. The patient subsequently experienced diarrhea while on therapy with ROTATEQ (MSD, WAES # 1006USA00596). No further information is available.
scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 15Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 12Apr2021 but tested positive for COVID that day. The patient wanted to know when to receive the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
A low grade fever started approximately 5 hours after the vaccine paired with overall feeling of being run down and achy muscles. The injection site was very sore and it was hard to move my arm. Symptoms subsided by 36 hours post vaccine.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) 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: HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed increased swelling and redness at site of injection. Was seen at the PMD's office the next day, where she was diagnosed with cellulitis around the area of injection. Clindamycin was prescribed for the skin infection.
Menstrual period late by 6 days (I have not been late more than once in the past 5 years)  Fever of 101.1 around 24 hr after vaccine. Fever slowly subsided but took a couple days.  Achy joints especially in fingers and toes, ankles for a few days after vaccine
Client presented to clinic on 5/4/18 with rash spread in clusters along thigh. Rash with pustules was red and warm to touch. Client's mother denies any ointment or treatment put on prior to coming in. Referred to Urgent Care for evaluation.
Pt recvd vax & w/in a couple of hrs inject exp dry mouth, cold sweat, queasy stomach & was lightheaded;
The evening of the vaccine I noticed a round red hard painful bump right below the injection site. It measures about 3 inches. It is still the same two days later. The day after the vaccine I experienced flu-like symptoms: body aches, headache, loss of appetite, tiredness, malaise and chills. My right hand, especially, was extremely cold. I couldn't seem to warm it up. Today (two days after the vaccine) I feel much better although still have a slight headache and some body aches. And, as mentioned, the arm is still very red and sore.
This spontaneous report as received from a pharmacist refers to an 81 year old female patient with diabetic, hyperthyroidism and sulfur allergy. On 16-APR-2013 the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot# J000436, expired date 10-APR-2014) subcutaneously. No concomitant medications. The next day, on 17-APR-2013 the patient experienced "weak and tired", and the patient also stated the injection site area was "slightly pink". On 30-APR-2013 the patient sought medical attention, at an unspecified primary healthcare provider. No lab diagnostics studies were performed. No treatment was given. At the time of this report the patient had not recovered. The pharmacist did not assess drug relationship. Additional information has been requested.
Left upper arm with edema & very slight erythema s/p injections of ADACEL & MENACTRA. Entire circumference of upper arm 1-1.5 inch larger than right arm.
pt recv vax & devel an intense,burning pain @ the inj site which lasted about 10min;pt also screamed for a good 10min;
vial that was exposed to temperature excursion was administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No relevant past medical history was provided.     On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient) outcome was unknown.        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.   .
Patient was lightheaded about five minutes after does.  I gave her an icepack behind the neck, sat with her and she was better .
Fever chills joint and muscle aches headache fatigue beginning about six hours after receiving the vaccine
Skin Reaction with blisters on both feet. alike chicken pots or shingles.
Numbness of extremities, flu, loss of appetite, headache, sluggishness, joint pain, loss of coordination, and confusion.
Vomiting the evening after shot, chills, temperature of 102.2 next day, fatigue, headache lasting 3 days (so far), COViD arm rash on left arm below injection site on third day
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a second 0.5 ml dose of VARIVAX (Merck) (therapy route and lot # not provided). The reporter stated that the patient came into her office "today", on 24-FEB-2011 who had developed chicken pox, even though the patient had been given VARIVAX (Merck) in the past. At the time of reporting, the patient's status was not provided. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Case number PHEH2014US022092, is an initial spontaneous report from a physician received on 31 OCT 2014. This report refers to female patient of unknown age.  Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly on an unknown date. It was reported that the patient received FLUVIRIN that was mixed in the same vial with Provera Depo. No adverse event reported. No further information provided.
for three days. redness and soreness on left upper arm just below injection site. At 6:30 PM on 2/27/2020 had severe shakes, and chills. Lasted about three hours. Still felt effects for about 24 hours
No additional AEs; Caller reports vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse and refers to a specified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-MAY-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 ml, lot # U031560, expiration date: 06-APR-2023, administered subcutaneously (strength was not provided) for prophylaxis. Prior to being administered, the vaccine experienced a temperature excursion of 10 degrees Fahrenheit for 14 minutes (product storage error). There were no previous temperature excursions. No additional adverse event reported (no adverse event).
Large, bright red, swollen rash at injection site appeared approximately 12 hours after receiving the second dose (no rash reaction to first dose). Rash is approximately five inches in diameter, mildly itchy, and skin is hot to the touch. The arm was extremely sore and tender the following day, but now four days post-injection the pain has dissipated but the large bright rash remains. I will wait one week and if it has not cleared up or reduced in size by then, I will seek medical care.
sick; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a female patient (age unspecified) who became sick (malaise) five times when she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (malaise) five times (unknown latency, non-serious event) everytime following the administration of INFLUENZA VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Case number PHEH2014US023372 is an initial spontaneous report received from a medical assistant on 19 Nov 2014. This report refers to a 19 years old male patient. His medical history and concomitant were not reported. He was vaccinated with 0.5 ml intramuscular MENVEO (batch number: M14040) on 17 Nov 2014. It was reported that the administered vaccine was stored below recommended temperature for a week. No adverse events were reported following the inadvertent administration.