chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient was diagnosed with a breakthrough case of covid-19 on 9/14/2021 despite being vaccinated with the covid vaccine on 12/29/2020 and 1/26/2021
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for two patients. This is the second of the two reports. A female patient of an unspecified age, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced pain at the injection site and the arm hurt for a few days. Clinical outcome of the events was unknown at time of this report. Sender's Comments: Linked Report(s): US-PFIZER INC-2017313813 Same reporter/drug/event, different patient.
Patient had a 6 by 3 in reaction.  Very red, swollen and hot to touch.  No other symptoms were noted.
Left arm was very painful, hot and swollen. On 11/14, patient noticed two red patches around her two BCG vaccine scars. The injection location is on one of the scars. Pain and swelling  started to improve today-11/16.  Patient's first two COVID vaccines were given on patient's right arm where she only has one BCG scar, much lower from injection site. She didn't have this reaction both times. Patient is having the same reaction as what was described in the following article: website.
pt recv vax 19MAY95 & 6JUN95 pt devel 3 non-vesicular lesions on the back; lesions persisted over a 24hr period; No further details were provided; Information has been received from a physician, who is the patient's mother, concerning her 31-month-old child, who was adopted from China, and was reported as a healthy child, who on 20-MAY-1995 at 12:05 PM was vaccinated in the left arm with a first dose of VARIVAX (Lot #608318/0403B). There was no concomitant therapy. On 09-JUN-1995 at 17:00 PM the patient developed a papular rash on the back that consisted of four to five non-vesicular lesions. The lesions persisted over a twenty-four hour period. In follow-up, the physician reported that over the next one to two weeks, the child developed continuous outbreaks of one to two non-vesicular, non-pruritic lesions at a time. The child continued to go to daycare and exposed other non-vaccinated children who had no history of having had chicken pox, and there was no secondary transmission. The patient was not ill at the time of vaccination and there was no relevent laboratory or diagnostic tests performed. On 20-JUN-1995, the child recovered without treatment. Additional follow-up received from the patient's mother, a physician, reported that her child received the chickenpox vaccine and had "breakout" in second grade (approximately 2000). The reporter, who is the patient's mother and is a physician also mentioned that the patient's sibling experienced a similar reaction following vaccination with VARIVAX (WAES# 0503USA03695).
a 57 year old female who received the high dose vaccination/ no AE; a 57 year old female who received the high dose vaccination/ no AE; Initial information received on 13-Apr-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 57 years old female patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It is an actual case of medication error due to inappropriate age at vaccine administration and overdose. It was reported that a 57 year old female who received the high dose vaccination.  At the time of this report, no adverse event was reported.  There will be no information available on the batch number for this case.   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 Directive and Module VI of the 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.
Pt received vaccine on 7/31/23. On morning of 8/2/23, he was noted to have a bruise on his Right upper thigh, surrounded by welts. Parent thought patient maybe had been bitten by older sister, but no event witnessed, and sister denies biting. Seen in clinic. Had a 2.5 cm bruise medially adjacent to Right upper thigh puncture site. There was a border of urticarial lesions about 8mm-1cm each surrounding the bruise. No other findings of angioedema on the body, nor other urticarial lesions noted. No respiratory or gastrointestinal symptoms.
DIscomfort; Felt a lump/ lump was the size of silver dollar; Really itchy and horrible; rash got larger and looked like "measles; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; rash, swelling and hurting at injection site; "Felt it throughout her whole body"; Pain above anklesand Pain to touch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar) and PRURITUS (Really itchy and horrible) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M(??)A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholesterol high. Concurrent medical conditions included Drug allergy (Naproxen,), Drug allergy (Codeine), Food allergy (Pineapple , Acidic fruits) and Drug allergy (allergic reaction to the Benadryl tablet). Concomitant products included HYDROCHLOROTHIAZIDE, TRIAMTERENE (DYAZIDE) and ATORVASTATIN for an unknown indication.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced FEELING ABNORMAL ("Felt it throughout her whole body") and PAIN (Pain above anklesand Pain to touch). On 16-Feb-2021, the patient experienced DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), RASH (rash got larger and looked like "measles), VACCINATION SITE RASH (rash, swelling and hurting at injection site), VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and IBUPROFEN (ADVIL 12 HOUR) at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL ("Felt it throughout her whole body"), PAIN (Pain above anklesand Pain to touch), DISCOMFORT (DIscomfort), NODULE (Felt a lump/ lump was the size of silver dollar), PRURITUS (Really itchy and horrible), VACCINATION SITE RASH (rash, swelling and hurting at injection site) and VACCINATION SITE PAIN (rash, swelling and hurting at injection site) outcome was unknown and RASH (rash got larger and looked like "measles) and VACCINATION SITE SWELLING (rash, swelling and hurting at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-047860 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Added medical history. Treatment drug information is added.
0845 - Pain behind left ear. 1010 - Red arms. 1030 - Red face, itching - hives with bumps on arms, back, face.
This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 09Nov2021 at 12:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks of vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 09Nov2021 at 13:00, the patient experienced severe migraines, nausea, neurological problems - numbness and loss of sensation in hands- intermittent but severe when it occurred. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe migraines, nausea, neurological problems - numbness and loss of sensation in hands- intermittent but severe when it occurs were not resolved at the time of this report.
Red puffy rash on left arm.  3 Inches by approx 1 inch.  Not symmetrical.   Using over the counter medicine steroid cream to treat.
Vasovagal Syncope (Fainting) - Felt hot and sweaty, then lightheaded 5-10 minutes after vaccine administration.   C5 fracture secondary to fall from the syncopal episode.
very hot, red, hard & swollen area @ inj site;only given because had an unspecified allerg rxn to a prev dose of vax;last prior doses was in childhood;
Patient was given entire, undiluted, vial of vaccine. Pt states he began to get sick that night and worsened on Saturday.  Chest pain (more muscular) ,body aches, joint pain. No fever or SOB
Initial unsolicited report received from a consumer on 26-Sep-2017. This case involves a 21-year-old patient (gender not reported) who was vaccinated with a 0.5 ml single dose of ADACEL (batch number, expiry date was not reported) in right arm via intramuscular route on 26-Sep-2017. The patient's medical history and concomitant medications were not reported. On 26-Sep-2017, same day following the vaccination, the patient experienced chest tight, mouth and throat itchy, difficult to breathe, mucous in chest and nose, hot, red and nauseated. Laboratory data was not reported. The patient received corrective treatment with BENADRYL. At the time of report the patient was recovering from the events. List of documents held by sender: none.
fever to 103.5 x 2 wks, chills, noc sweats, muscle aches; flatus, no fever p/7NOV92;
Rashes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes) in an 85-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes). At the time of the report, RASH (Rashes) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not reported.  Patient developed symptoms (rashes) after vaccination with the Moderna vaccine. Treatment details were not reported.  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.
26SEP91 pt awoke w/swollen, painful joints; few hrs later pt exp sore throat, h/a, chest, pain & fever; @ MN vomiting, chills & fever began; 27SEP91 presented to ER w/4-5 day hx of upper respiratory tract infection type sxs; see WORM...
Diagnosed with Guillian Barre Syndrome after showing signs of weakness in legs, muscles, numbness in feet and legs, and hands.  Experienced  balance problems, falling, entered ER on May 28,   Could not walk, spinal tab done and confirmed Guillian Barre Syndrome virus.   Was treated with 2 courses of IGIV in hospital and 3 more courses as outpatient.  Reentered ER on June 27, 2021 after falling from weakness in legs.  Spinal tap confirmed GBS. Given 2 more courses of IGIV,  sent to Rehab hospital for 6 weeks with 2 more courses of IG,  Sent home with home care and receiving 2 courses of IGIV every 3 weeks through December 2021
body wet/drenched in the middle of the night; drained and can't function; fever 8 hrs after vaccine (102.5); This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (body wet/drenched in the middle of the night), PYREXIA (fever 8 hrs after vaccine (102.5)) and FATIGUE (drained and can't function) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Breast cancer (lumpectomy-left breast). Concomitant products included EXEMESTANE for Breast cancer, PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, APIXABAN (ELIQUIS) and METOPROLOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (fever 8 hrs after vaccine (102.5)). On 14-Mar-2021, the patient experienced HYPERHIDROSIS (body wet/drenched in the middle of the night) and FATIGUE (drained and can't function). On 14-Mar-2021, HYPERHIDROSIS (body wet/drenched in the middle of the night) had resolved. On 15-Mar-2021, PYREXIA (fever 8 hrs after vaccine (102.5)) had resolved. At the time of the report, FATIGUE (drained and can't function) had not resolved.            Treatment of events was not reported.
Patient stated she became itchy, and her arm was burning, her chest felt tight with a feeling of impending doom, and pallor.
This spontaneous report as received from office manager (other health professional) refers to a patient of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On 21-NOV-2016, the patient was vaccinated with PNEUMOVAX 23 (dosage regimen were not reported) (Lot # M041394, expiry date: 23-MAY-2018) that may have experienced a temperature excursion in transit as it was delivered later than scheduled to the practice. The vaccine was shipped on 18-NOV-2016, and was received on 21-NOV-2016. The vaccine was supposed to be a two-day shipment. Temperature excursion data was unknown since the excursion was related to a late shipment. Data logger was not used to log temperatures and there were no previous excursions. No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No additional information provided. Lot number M041394 has been verified to be a valid lot number for PNEUMOVAX 23. Additional information has been requested.
pt recv vax; on 9may96, exp greater than 100 lesions over entire body and fever; no further details provided;
Left arm deltoid area with about 3cm red, hard, tender. Gave Benadryl  cream and Zyrtec.
Had DTaP left arm 3/17/04- on 3/18/04 swollen, red, size of fist- temp 101 & soreness- went to ER given Benadryl, steroid & antibiotics after ER- to soak arm- no prescription for home- Continue Benadryl, Tylenol.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/14/2021.
I started having skin inflammation / small areas of rashes on parts of my body about 2 weeks after my booster. This occurred if I was especially stressed or tired.  I have never experienced this before and have no history of severe flair-ups like this.  The inflammations were itchy and flaired up more if I would itch the area.  Rashy/itchy areas could be as small as an itch or widespread depending on if I itched them and would turn into welts.  The skin woud feel hot and I would get a burning sensation along with itching the area.  I am able to find relief by taking 1 benedryl twice a day as needed and using hydrocortosone cream on particularly bothersome flair-ups.  But I have also found relief in lavender lotions and gold bond lotion.  The inflammation is on-going.  I have considered going go my doctor when I hadn't yet known that benedryl and lotions/cream helped.  It is not severe enough to seek my doctors' help, but it is still very bothersome and I have to be prepared for a flair-up.
Positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got her first dose 01apr2021 and was scheduled for her second 22Apr2021, but before she got her second dose, on 14Apr2021, she tested positive for COVID. The outcome of the event was unknown.   Information on Batch number/Lot number has been requested
1100-Patient started experiencing dizziness, clammy skin, green in color on face, sweating, patient had drank one soda. Up all night, and anxiety for 3 days prior to vaccine. Patient placed lying on table with water and cracker given. Patient recovered.
Immediately after I got it I started feeling flush and hot in my face, I got dizzy and lightheaded, my HR went to 180, my legs felt weak, I was having chest palpitations and chest pain. I felt really dizzy and nauseated, I felt like I could not walk. I felt like I hit by a bus. The next day I had heavy flu symptoms, high fever, continuous chest pain and high HR, at the ER they gave me a high dose of Benadryl, steroids and fluids. I took Benadryl for about 7 days and I still felt light headed palpitations and fever for almost 2 weeks. I also was tested for COVID and it was negative. I was advised to not take the second vaccine. I still have a really bad fatigue. It is the symptom that is still on and off.
This was my second dose.   Fever as high as 103.4F.  Fever lasted 24 hours above 100.0F  Chills, Shaking for 4 hours from about 8/9 pm to 12/1am.  Nausea, vomiting, bowel pain, inflamed rectum after bowel movement the next day, loss of hearing, dizziness, Trying to sleep and waking up gasping for air about 5 times though out the early morning. Sever Headache which lasted Two and a half days.    About 2 pm on 2/5/21 I took some Emetrol for the Nausea, and Tylenol for headache and fever.   I took Tylenol again the evening of 2/5/21.  On 2/6/21 I Tylenol and then Ibuprofen then Excedrin.  On 2/7/21 I took Excedrin once and my headache was finally gone.
Starting morning of 9/23/17 (patient was vaccinated on 9/22/2017), patient developed nausea and had symptoms of nausea/vomiting, fever of 102, headache, and very sore arm (in the arm in which she received FLUARIX and PNEUMOVAX). Patient reported that she had symptoms on all day on 9/23/17 and 9/24/17. On 9/25/17, patient stated that she has noticed improvement overall.
Itchiness at the site of injection; Rash above the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the site of injection) and VACCINATION SITE RASH (Rash above the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided.
Within hours of receiving the first HPV Gardasil shot, my daughter experienced irregular menstrual bleeding for 7 days. She had just had her regular menstrual cycle 2 weeks prior to the vaccination.
Low grade fever, chills, body ache, head ache, extremely tired for about 18 hours.
Severe chills 8 hours after injection. Fever of 102, body aches, 8-16 hours after. Fever of 100, body aches, nausea, fatigue 16-30 hours after injection.
Seizure at 0400 on 3/9/2019. Temp measured by EMS 101 after seizure.
swelling of her face; numbness in arms; numbness in hands; tingling in her feet; some throat issue, voice hoarse, tight, but not like closing; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20a) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing). On 26-Jan-2021, SWELLING FACE (swelling of her face), HYPOAESTHESIA (numbness in arms), HYPOAESTHESIA (numbness in hands), PARAESTHESIA (tingling in her feet) and DYSPHONIA (some throat issue, voice hoarse, tight, but not like closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details steroids and EPI-Pen.
After my period ended, three days later it started again - a lot of red blood, and it is extremely painful - never had such painful period before, to the point of crying and screaming when the eggs were moving through the fallopian tubes;  it  is not stopping and I feel weak and tired and unfocused. We considered ER but waiting to see if improves over time. Today is day three.
PT L thigh muscle became red and edematous localized soreness by evening of injections. (after riding a horse in afternoon). Taken to PCP the following day. Cool packs, Benadryl and Ibuprofen and antibiotic (mother did not know which) started antibiotics soreness for 2 days.