chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Skin under and around Both EYEsred, itching, swollen/Puffy; Skin under and around Both EYEsred, itching; Skin under and around Both EYEsred, itching, swollen, burning; Skin under and around Both EYEsred, itching, swollen, burning, puffy,inflamed; Skin under and around Both EYEsred, itching, swollen, burning, puffy,inflamed and irritated; Skin under and around Both EYEs red; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0172) via an unspecified route of administration in the left arm on 02May2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 00:00, the patient experienced skin under and around both eyes red, itching, swollen, burning, puffy, inflamed and irritated. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with Eyedrops and hydrocortisone. The clinical outcome of the events skin under and around both eyes red, itching, swollen, burning, puffy, inflamed, and irritated was not recovered. Patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 23May2021 at 12:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Around 3:15 pm , patient was given immunization of prevnar and fluzone high dose both in left deltoid as agreed to by the patient. about 5:20 pm patient's wife called rather frantic because he had become pale and shaky. Instructed her to lie him on his backs and rest his legs on the couch to help regain circulation to the upper portion of the body. A few minutes later the daughter got on the phone and said he was starting to have trouble breathing, so I instructed them to call 911 or got to the nearest emergency room due to the presentation of shortness of breath as I could not rule out some sort of reaction to the vaccination causing this.
Transformed my life, gave psoriasis; Ruined my confidence; This case was reported by a consumer via interactive digital media and described the occurrence of psoriasis in a patient who received HPV 16-18 (HPV vaccine) for prophylaxis.   On an unknown date, the patient received HPV vaccine. On an unknown date, unknown after receiving HPV vaccine, the patient experienced psoriasis and loss of confidence. On an unknown date, the outcome of the psoriasis and loss of confidence were unknown.   It was unknown if the reporter considered the psoriasis and loss of confidence to be related to HPV vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient stated that, the HPV vaccine certainly transformed his/her life, gave him/her psoriasis and ruined his/her confidence for entire adult life. The follow-up would not possible as no contact details were available.
Patient developed redness which started at Prevnar site. She developed erythematous papules on left upper arm, left fingers and face. She was treated with Atarax.
small paular rash that started distal to the vaccine site and went down arm, slighly pruritic
Hospitalization and death. From vital records: CARDIORESPIRATORY FAILURE, HYPOXIA, COVID-19 PNEUMONIA, Per vital records, COD ICD Codes include: Not yet coded ; Other Significant Conditions include: None listed
approx 20min p/vax devel urticaria @ lt shoulder/arm inj site;DPH given w/urticaria clearing 30-40min thereafter pt given DPH to take home q 6hr PRN;
pt recvd vax approx 10AM & arrived home 1230; 1st dose APAP given; mom states sl warm, t106 to MD;
noticed a red spot just below the injection site; slightly raised/not getting smaller; sensitive to touch/only hurts when I press on it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (noticed a red spot just below the injection site), VACCINATION SITE SWELLING (slightly raised/not getting smaller) and VACCINATION SITE PAIN (sensitive to touch/only hurts when I press on it) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (noticed a red spot just below the injection site), VACCINATION SITE SWELLING (slightly raised/not getting smaller) and VACCINATION SITE PAIN (sensitive to touch/only hurts when I press on it). At the time of the report, VACCINATION SITE ERYTHEMA (noticed a red spot just below the injection site), VACCINATION SITE SWELLING (slightly raised/not getting smaller) and VACCINATION SITE PAIN (sensitive to touch/only hurts when I press on it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Low grade fever, right arm swelling at site of injection, hard, by hospital had cellulitis.
3 pt recv vax & devel mild breakthrough of varicella w/greater than 20 lesions but less than 50;
Information has been received from a health professional concerning a 5 year old female who on 05-SEP-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On Friday, 09-MAR-2007, the patient started breaking out in a rash, which the mother thought to be chickenpox. On 12 MAR 2007 the patient presented for an office visit with "definite chickenpox" over her trunk, groin and in her hairline. Supportive measures were disused, and instructions for returning to school. Given that the patient was afebrile, she was vaccinated, at the same visit, subcutaneously, into the left arm, with a "booster" dose of varicella virus vaccine live (Oka/Merck) (Lot # 653971/0796F). At the time of reporting the patient was considered recovered. Additional information is not expected.
Moderate to severe pain and limitation in shoulder, upper arm, under the arm & under left shoulder blade.  Pain can be a throbbing sensation or a shooting pain if I move or lift my left arm in a certain way,  Very difficult and painful if I try to lift a clothing item above my head, put my left arm through  a sleeve of clothing, put my hair in a ponytail, pull my left  arm over to sleep on my right side, when I put my seatbelt on before driving or turn my steering wheel as I back out of my driveway.  I have been in contact with my physician on several occasions.  The pain has not subsided and actually feels worse.
Body pain, headache, tiredness, chills, fever and nausea, around 9pm
38 weeks pregnancy patient who received the first dose of the Moderna COVID-19; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19) in a 27-year-old female patient (gravida 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Spontaneous abortion in January 2019, Spontaneous abortion in April 2019 and Ex-alcohol user (Twice a year). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 09-Mar-2021. On 26-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-seventh week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 26-Feb-2021, EXPOSURE DURING PREGNANCY (38 weeks pregnancy patient who received the first dose of the Moderna COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Prenatal screening test: inconclusive (Inconclusive) healthy. On an unknown date, Ultrasound foetal: inconclusive (Inconclusive) No red flags.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Patient was administered with an extra dose of Menactra with no reported adverse event;Initial information regarding an unsolicited valid non-serious case was received from other health professional via a consumer/non-health care professional via Medical Information (Reference number- 00818817) and transmitted to Sanofi on 19-Oct-2021.   This case involves a 17 year old male patient who was received a third dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Extra dose administered].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT) for prophylactic vaccination.  On 15-Oct-2021, the patient received a 0.5 mL third dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U7191AA, expiry: 18-Jan-2023) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Extra dose administered (latency same day).  It was reported "Office manager calling in regards to a third dose of MENACTRA being administered to a patient. Caller would like to know if there are any implications or adverse effects they should be on the lookout for? Patient was administered an extra dose of MENACTRA at an office visit."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Two days after receiving vaccinations on 12/15/2021, parent of patient reported a high fever (103 degrees and fatigue). After further testing (covid, strep and flu) at the Emergency Department all tests were negative. Patient came in office on 1/4/22 with reports of high fevers (104) on and off with hallucinations that occur with and without fevers present. Patient was also lethargic and decreased appetite. All tests in the clinic were negative at office visit on 1/4/22. Provider ordered further labs and neurology referral.
Itchy; Lighter in color; oval pink spot on her arm/It had a darker blemish inside that was about 4in; Looks like bleeding under the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Looks like bleeding under the skin), PRURITUS (Itchy), SKIN DISCOLOURATION (Lighter in color) and VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 031L20A and 001B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included WARFARIN for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced SKIN HAEMORRHAGE (Looks like bleeding under the skin). 06-Nov-2021, the patient experienced VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in). On 07-Nov-2021, the patient experienced PRURITUS (Itchy) and SKIN DISCOLOURATION (Lighter in color). At the time of the report, SKIN HAEMORRHAGE (Looks like bleeding under the skin) and PRURITUS (Itchy) outcome was unknown and SKIN DISCOLOURATION (Lighter in color) and VACCINATION SITE ERYTHEMA (oval pink spot on her arm/It had a darker blemish inside that was about 4in) was resolving.            No treatment medications were reported Patient provided information that she received flu vaccine the same date in the opposite arm (left).
mother noted thigh swelling at injection site two days after immunization.  Patient was seen in office and examined: left thigh with 10x6 cm indurated, erythematous, tender. No fever, no systemic symptoms
His wife is not feeling well that's why they cannot get their dose today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (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: MALAISE (non-serious) with onset 05May2021, outcome "unknown", described as "his wife is not feeling well that's why they cannot get their dose today".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021517115
This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 29Mar2021 at 16:30 (at the age of 22-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history reported. Concomitant medications included escitalopram 10 mg (MANUFACTURER UNKNOWN) and ethinylestradiol, norgestimate (TRI FEMYNOR); both started on an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 09Mar2021 at 16:30 (at the age of 22-year-old), as a single dose for COVID-19 immunisation. It was unknown if the patient had any known allergies to food, medications or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at 12:00, the patient experienced severe muscle aches, hypersensitive skin (washing hands was uncomfortable and anything bumped into was hurt 100 times worse), headaches, chills and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any therapeutic treatment for muscle aches, hypersensitive skin, headaches, chills and fatigue. The clinical outcomes of the events severe muscle aches, hypersensitive skin, headaches, chills and fatigue were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6 mo male seen yesterday by Dr. for 6 mo WCC, normal healthy history and exam - received PEDIARIX, Hib, PREVNAR and ROTARIX.  Acted his usual normal self except some mild increased fussiness yesterday evening.  Fed normally until and including 3am feed at breast (exclusive breast).  Refused breast until 10am - fed only for few minutes and not aggressively (examined at 11am).  Mom and grand mother note he had a temperature elevation to 99.1, but then began to feel even warmer and became limp lasting for approximately 2hours.  They do not describe any seizure like activity (although the limp behavior is puzzling for possible post-ictal state).  His last wet was at 5am and was a little wet in the office on exam.
tenderness; felt very fatigued; This is a spontaneous report from a contactable healthcare professional (patient). This 57-year-old female patient received dose 2 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EL1284) intramuscularly on 03Feb2021 (at the age of 57-years-old) as a single dose in the right deltoid for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination.  The patient previously received dose 1 of BNT162B2 (lot number EK4176) on 09Jan2021 as a single dose in the left arm for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced tenderness and felt very fatigued for about 24 hours. The patient was not hospitalized for the events. The patient did not receive any treatment for the events. The outcomes of tenderness and very fatigued were unknown.   No follow-up attempts are needed. No further information is expected.
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th December 2019, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient developed shingles across her face. The reporter consented to follow up.
Moderna COVID-19 Vaccine EUA I experienced side effects including fever, nausea, headache, chills, fatigue, muscle and joint aching.
Vertigo, nausea and vomiting for 36 hours, then dizziness and heavy fatigue for five days
antibody test negative; Literature Report.  This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 34-year-old female patient.  The patient's medical history included multilobar pneumonia, respiratory failure, bronchiectasis, purpura, and bruising. The patient's concurrent conditions included hair thinning with alopecia, skin depigmentation, leukopenia, lymphopenia, asthma chronic, upper respiratory tract infection, alopecia areata, vitiligo, infertility. The patient was a lifetime nonsmoker. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with polysaccharide pneumococcal vaccine, (manufacturer unknown) injection, administered for prophylaxis (exact dose, lot #, expiry date, and route of administration were not provided).   Before vaccine booster (pre-allogenic HCT), the patient's Streptococcal pneumoniae antibodytest was 3 of 14 serotypes. After vaccine booster (post-allogenic HCT; 1 year) the result of test was reported as off IgRT postimmunizations). Therefore,the patient displayed poor antibody response to polysaccharide pneumococcal vaccine (manufacturer unknown) despite receiving a booster. The outcome of the event was not reported.  The event was considered as to be related to polysaccharide pneumococcal vaccine (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
pt  began w/in hr resolved w/in 48hr of inj swelling lt side of face, arm, lymph nodes, fever, n/v;gen aching/malaise;
Severe nerve pain; This case was reported by a pharmacist via call center representative and described the occurrence of nerve pain in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 27th April 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th April 2019, less than a day after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was recovering/resolving.   It was unknown if the reporter considered the nerve pain to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix vaccine in right arm. The patient developed severe nerve pain in her right thigh later that same evening. The pain was getting better, but did not gone away completely.
Vaccine was administered after 12hours  post puncture. Vaccine was at 72 degrees F.
High fever, malaise, full body aches and chills that came on ~ 8 hrs after the 2nd vaccination and lasted ~ 24 hours.
The next day every muscle got hard and cramped. Intense headache, 104-106 temperature, could not walk pain was intense. Pain radiating down arms. Chest muscles so tight it felt like a heart attack. Every muscle and joint so painful. For a 59 year old male to have to stay in bed and just cry from the pain. I needed help even to the bathroom. Never would I ever recommend this to anyone. Very worried whether I'll have side effects.
At approximately 1200 parents alerted EMT/paramedic in observation, child fainted, parents carried child to cot with EMT assistance. NP notified by MA of situation. Upon arrival of NP, child pale, diaphoretic, eyes open to verbal stimuli (name calling). Vital signs at 1202 BP 90/62, P 71, R 24, SpO2 98% RA, Temp 96.9. Granola bar and water provided by EMT. Patient abale to eat and drink. Child stated ?I?m starting rii feel better?. Patients father stated that ?he passed out before and he?s gotten dizzy with shots in the past?. Parents advised to ensure child has eated and drank fluids before all future vaccines. Parents also encouraged to have medical staff have the patient lie down for future immunizations. Vital signs repeated with no abnormal results. Patient left observation with parents in stable condition at 1220.
I got COVID and tested positive January 5,2023 and was prescribed paxlovid and took it for two days. I had a fever, chills and body aches that lasted three days. I was weak and started recovering about the 4th day and probably was tired and not my normal self for about 30 days. I'm pretty much back to normal now.
Pt developed cellulitis and subsequently admitted to exclude necrotizing fasciitis.  Pt vaccinated 4 Sept 07 and had onset of chills and erythema same day.  She was admitted 7 sept 07.  Unfortunately, all 3 vacines were given in same deltoid - provider counselled.
Severe Myalgia, Extreme fatigue, mild headache, chills and nasal congestion
Patient went to restroom and starting feeling lightheaded, after 15 minutes, patient said feeling ok to go home.  Patient called the Pharmacy on Sunday September 25th, stating was sweating a lot at night, felt faint, and vomiting.  During conversation patient said no breathing problems,, or  any allergic type reactions, told patient should go see or call provider if condition worsens.
Client was given adult dose instead of pediatric dose by nurse. She did not realize mistake until after they had left facility. This nurse sup called parent to explain incident and check on well being of child.