chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Nov2022 at 12:00 as dose 2, single (Lot number: PF13CLLGH9697) at the age of 28 years, in left arm for covid-19 immunization; influenza vaccine (FLU VACCINE VII), on 03Nov2022 as dose 2, single (Batch/Lot number: unknown), in left arm for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: PF13ELFP7150; Location of injection: Arm Left; Administration Time: 12:00 PM), administration date: 07Sep2022, when the patient was 28-year-old, for Covid-19 Immunization; Flu (DOSE 1), for Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 03Nov2022, outcome "unknown", described as "Pfizer bivalent start date: 03Nov2022; Flu shot start date: 03Nov2022"; OFF LABEL USE (non-serious) with onset 03Nov2022, outcome "unknown", described as "pfizer Bivalent/dose 2"; HYPOAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "numbness"; PARAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "pins, and needles sensation in the left side of body - hands, forearm, feet, calf, knee, thigh"; PARAESTHESIA (non-serious) with onset 03Nov2022 at 12:30, outcome "not recovered", described as "tingle". The events "tingle", "numbness" and "pins, and needles sensation in the left side of body - hands, forearm, feet, calf, knee, thigh" required physician office visit. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia, paraesthesia.
Patient stated she had chills at 5 pm, woke with fever of 100.2 this morning, aches all over, and right arm really sore.
26.5 cm diameter of left upper arm.  Area of erythema 12 x 13 cm on left lateral upper arm.  Pain with range of movement in deltoid, warm to the touch.
I rcvd the vaccine around 3 and then around 10-10.5 hours later I felt extremely chilled, so much so I had to clench my teeth together. I had uncontrolled shaking almost like tremors. This lasted a little over one hour. I Drank more water to hopefully help. I went back to bed about within a half hour but the tremors came back again with extreme shaking and chills and again I had to clench my teeth. I drank more water. They kept coming in cycles and came less and less until I was able to stay in bed. I was tired the next day but that was the main thing I noticed after receiving the Pfizer covid bivalent booster shot. I don't recall experiencing anything like this with my previous shot on 11/2/2022. I have lasting fatigue.
Negative antibodies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Negative antibodies) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Back injury in 1989. Concurrent medical conditions included Disease Crohns since 2004, Asthma since 1973, Hypertension since 2004, Anxiety since 2004 and Drug allergy (Cephalosporin). Concomitant products included LORAZEPAM (ATIVAN) for Anxiety, ALBUTEROL [SALBUTAMOL] for Asthma, TIZANIDINE HYDROCHLORIDE (TIZADINE) for Back injury, INFLIXIMAB (REMICADE) for Crohns disease aggravated, LISINOPRIL for Hypertension, RANITIDINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION FAILURE (Negative antibodies). At the time of the report, VACCINATION FAILURE (Negative antibodies) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Company comment: This report refers to a case of vaccination failure (negative antibodies)  for mRNA-1273, ( lot # 030A21A) with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-094954 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up document was received on 29-Jul-2021.Added relevant medical history, concomitant medications, lad data, Event start date.; Sender's Comments: This report refers to a case of vaccination failure (negative antibodies)  for mRNA-1273, ( lot # 030A21A) with no associated AEs. US-MODERNATX, INC.-MOD-2021-094954:Husband case
Worsening of severe lower back pain and sciatica. Difficulty with movement, shooting nerve pain in left leg. Ongoing.
Swollen lips. Heart palpitations 2 hours after immunization. EPI 3 SQ and DepoMedrol 120mg IV Allergic reaction
Pt developed rash on chest, tingling in abdominal area, and anxiousness. Pt given zyretec 10mg PO with water, monitored closely for 1 hr.  Instructed per Dr. not to have the second dose administered and to discuss with her physician. Symptoms subsided and pt sent home.
I noticed a rash on my hand and my wrist. On the top of my hand near the thumb area. It was a little itch, and I was scratching. It was on the same are on both hands. It was persistent and did not go away. I saw a dermatologist. She was unable to say what it was but did provide an ointment called clobetasol 0.05%. I used the ointment as directed and it cleared the rash up.  I used it for about a week and It disappeared. A week later, it reappeared again. I have scheduled another appointment with my dermatologist. I have been using the ointment in the meantime, which is helping with the itching, redness and clears it a little but it is still visible.
Slight pain at injection site for a couple days.  Then at day 7, itchy round rash developed at injection site.  Raised red area about 3 inches across, feels warm, and itches.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable Pharmacist. A 52-year-old male pharmacist reported that he received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown) intramuscular into the right arm on 08Jan2021 at 10:15 AM (at the age of 52-year-old) at single dose and the second dose of  BNT162b2 (lot number unknown) on 29Jan2021at single dose for COVID-19 immunization. The patient had not  known allergies or other medical history. The patient had not Covid prior vaccination. Concomitant medications in two weeks were none. No other vaccine was administered in four weeks. The patient reported that on 07Apr2021 at 21:00 he started experiencing symptom of runny nose / head/nose congestion even though he had the Vaccine. On 09Apr2021 he underwent a rapid Nasal Swab COVID 19 test and was positive for COVID. He was treated with Vitamins for cold / sinus. the patient reported that he is the 5% or the vaccine does not block virus from coming in and it just lessen/ reduces symptoms and duration of COVID. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Swab COVID 19 test and was positive  load based on the known safety profile.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received FLUARIX. Co-suspect products included FLULAVAL. In November 2015, the patient received FLUARIX and FLULAVAL. In 2015, less than a week after receiving FLUARIX and FLULAVAL, the patient experienced injection site pain and injection site swelling. In November 2015, the patient experienced wrong injection technique. On an unknown date, the outcome of the injection site pain and injection site swelling were recovered/resolving and the outcome of the wrong injection technique was unknown. The reporter considered the injection site pain and injection site swelling to be related to FLUARIX and FLULAVAL. Additional details were provided as follows: This case was previously reported to a manufacturer. This case was reported by a pharmacist, who herself was a mother of the patient. The reporter stated that about a week ago, in November 2015, the patient received either FLUARIX or FLULAVAL vaccine at a public health clinic. The patient experienced extreme pain and swelling in his arm (injection site). In the reporter's opinion, it was very abnormal in the way the vaccine was administered verses the way she would administer it. The vaccine was administered lower than what she would have administered and was not given in the deltoid region, which led to wrong injection technique. The reporter suggested that the pain and swelling was caused by FLUARIX and FLULAVAL vaccine. The reporter also took the picture of the patient's arm. The details regarding lot number, expiration date, if any other vaccines were administered on the same day or 4 weeks prior exact date of vaccination, name and date of birth of the patient, which arm the vaccine was administered and the date on which the swelling and pain started were unknown. The sales representative thought the swelling and pain has resolved because the vaccine was given about a week ago.
November 26, 2022, I had a headache that turned into coughing and congestion, and it went away after a couple of weeks.  But it came back in at the end of January it came back and would come and go for about 2 months.  I went to the doctor in March I had an X-Ray to check for pneumonia.
Red splotchy swollen rash - no treatment, 4 days later dizziness, itchy hands/feet and watery eyes - no treatment.
mom states pt went limp, turned blue around the mouth, & eyes rolled back;pt later exp convuls;taken to MD for tx & was told d/t vax;
discoloration of the skin; there are little spots,black spotches,they are not itchy but they were not there before; feeling itchy; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient (Age: 57; units: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 03Mar2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) on unspecified date as single dose for COVID-19 immunization. The patient received the 2nd dose of the Pfizer Covid vaccine on Wednesday, 03Mar2021. She received it in her left arm however she says on her right arm there are little spots, black splotches, they are not itchy but they were not there before skin discoloration. The patient had discoloration of the skin. She does report feeling itchy, but not in that area. The events occurred on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I started having tightness in my chest within an hour after the vaccine. Then I had tingling down my right arm. It worsened to the point where I felt like I could not take a deep breath
Information has been received from a nurse practitioner concerning a patient who on unspecified dates was vaccinated with 3 doses of GARDASIL vaccine (yeast) at another location. The nurse practitioner reported that her office did not realize that and started her on another series and administered 2 doses of GARDASIL vaccine. The patient received 5 doses of HPV vaccine in total. No adverse event reported. It is unknown if the patient sought medical attention. Additional information has been requested.
Intense muscle pain in left shoulder traveling down left side of back.; Painful to breathe at times. Lasting longer than expected.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old patient of unspecified gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route administration in left arm on 17Mar2021 at 02:45, as a single dose for COVID-19 immunisation. Medical history included depression and plantar fasciitis. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medications received within 2 weeks of vaccination included meloxicam (MANUFACTURER UNKNOWN), PREVAGEN, AMBEREN and CLARITIN all from unknown dates for unknown indication. On 18Mar2021, at 05:00, the patient experienced intense muscle pain in left shoulder traveling down left side of back. The patient felt painful to breathe at times (breathing difficult) which was lasting longer than expected. The patient did not receive any treatment for events. The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of muscle pain and breathing difficult was not resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Pateint recieved the Flu vaccine and was able to leave the administration area under his own power.  He was walking back to the pharmacy bench when he lost consciousness and passed out resulting in him striking the floor with the back of his head.  When we came to he was in pain and disoriented.
She is a breastfeeding mother of a 19 month old; Had sores in her mouth and tongue; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (She is a breastfeeding mother of a 19 month old) and STOMATITIS (Had sores in her mouth and tongue) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) and CLONIDINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (She is a breastfeeding mother of a 19 month old) and STOMATITIS (Had sores in her mouth and tongue). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (She is a breastfeeding mother of a 19 month old) and STOMATITIS (Had sores in her mouth and tongue) 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 medications were not provided.   This case was linked to MOD-2021-085546 (Parent-Child Link). This case was linked to MOD-2021-085519 (Patient Link).   See case MOD-2021-085546 for details regarding the child case.
It started with soreness at injection site. By late evening fatigue, swollen/sore joints, chills, low grade fever, headache, dizziness, nausea, abdominal pain, and dizziness set in. The injection site on right arm developed redness and swelling on Saturday morning and has worsened through Sunday. Nausea and decreased appetite has increased to Sunday night.
Intense diarrhea for 2 weeks, achiness at the site, stuffed sinuses, headache due to sinuses, stuffy and runny nose, cough, exhaustion, drainage from sinuses to throat, etc
Temp. 104.7, Face swelling, Headache, general edema (fingers, etc.) Continued fever avg. 101.4 12 days later.
Rash at site of injection. Treated with a topical anti-itch cream. Rash is resolving nicely.
14 hours after injection, temperature  went up to 102.2  degrees for   about 5-6 hours.  Then down to 100 degrees
On 11/26/99, the pt experienced a fever with about 20-25 skin lesions that appeared like red spots. Additional information has been requested.
burn from a side; This spontaneous case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (burn from a side) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (burn from a side). At the time of the report, SKIN BURNING SENSATION (burn from a side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
3/4/13 1610 Client received Gardasil, Varicella, & Menactra. At approx 1615 client was standing next to her mom & states "I don't feel well" RN & Mom took clients arm as syncope episode happened. Pale in color. Lowered client to floor and elevated her feet. Client aroused in less than a minute. BP 110/72. After approx 5 min assisted Client to standing and walked into exam room. 1625 patient reports feeling well, color pink, smiling walked out with Mom at side.
1 hour after vaccination, the patient started to experience nausea, which was followed with emesis and loose stool. The patient reported to clinic on 3 Dec 2019 with persistent symptoms of nausea, however with decreased emesis and loose stool. Despite symptoms, patient maintained normal vital signs. He also reports that vaccination in 2018 (Seqirus YF39708, 11 Oct 2018) he had the same symptoms that resulted in an emergency room visit for rehydration. Today, he was treated with zofran, counseled regarding hydration and diet, and sent home for 48 hours.
Booster; got covid the first time in September/The worst thing I got for Christmas...Covid; got covid the first time in September/The worst thing I got for Christmas...Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster dose), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 19Feb2021 (working off a very blurry image for this date) (Batch/Lot number: unknown) as dose 1, single (at age of 34-year-old) for covid-19 immunisation. Seemed like a date of 12Mar2021 may have been given for the target date of the second dose (unless this was a separate vaccine). It was unsure when received booster or when actually got second shot. Booster could have happened between both covid cases. Relevant medical history included: "has had issues with weight, unsure otherwise" (unspecified if ongoing); "potentially some mental health struggles" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2021, outcome "unknown" and all described as "got covid the first time in September/The worst thing I got for Christmas...COVID". The patient had COVID in Sep2021 (approximately 16 weeks ago), and now in Dec2021 the patient had it for a second time. The patient felt 100% better on last day of isolation when got COVID the first time in Sep2021. COVID was ongoing for the current Dec2021-Jan2022 case. The patient may have caught or contracted COVID around Christmas-time or got exposed to someone with COVID over Christmas. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Sep2021) positive; (Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Varivax given L deltoid, 1-7-08 at 14:15.  Pt developed 4 cm redness/rash to injection site by late Tuesday and a rash to her chest.  The rash is non-resonpt .  No vesicles.
Patient reported burning sensation on injection into left deltoid and localized painful reaction. Within approximately 10 minutes following injection, patient reported dizziness, weakness, and nausea.  Patient tried to stand and reported that she experienced syncope, fell, and struck her head.  Patient called out pharmacist's name. Pharmacist arrived to find patient lying on the floor. Patient had visible mark and bump on her forehead. Pharmacist elevated patient's feet. Patient elevated herself under her own power to a seated position. Patient was given water and blood pressure was taken. Blood pressure was 128/86 with a heart rate of 76. Patient requested pharmacist not contact 911. All events occurred within 15 minutes following vaccination.  Patient reported she would visit urgent care following departure from pharmacy but unknown if patient will follow-up. Patient left under her own power and was driven home by husband.
Information has been received from a certified medical assistant concerning a patient who in 2007 was vaccinated with a dose of GARDASIL. In 2009 the patient came up with an abnormal pap. In 2007 the patient had a LEEP procedure and in 2008 had a normal pap test. Additional information has been requested.
received a dose of an expired vial/The dose was administered 22 hours after first puncture; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial/The dose was administered 22 hours after first puncture) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial/The dose was administered 22 hours after first puncture). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of an expired vial/The dose was administered 22 hours after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 09-MAY-2013 the patient was vaccinated with ZOSTAVAX lot # 672428/1599AA, 0.65 ml, subcutaneous for prophylaxis. The patient was administered an expired dose (expiration date: 13-JAN-2013). No adverse event was reported. The patient sought medical attention by office visit. Additional information has been requested.
Extreme itching over entire body, extreme joint pain. Ear ringing  right  ear right eye pain tongue pain right side all from previous shingles, headache right side. Prescribed banophen 25 mg every six hours. I am still having symptoms 6 days later.