chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal bleeding; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 30-years-old female patient received first dose of bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 10Apr2021 16:45 (at the age of 30-years-old) as single dose for COVID-19 immunisation. Medical history included endometriosis from an unknown date and unknown if ongoing Other medical history: Endometriosis. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) taken for an unspecified indication from 12Mar2021 to 12Mar2021; cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported. On 11Apr2021 14:30, the patient experienced vaginal bleeding. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Suspected vaccination failure; Mild case of shingles; Welts; Very uncomfortable; Very itchy; This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, welts, discomfort and pruritus. On an unknown date, the outcome of the vaccination failure, shingles, welts, discomfort and pruritus were unknown.   The reporter considered the vaccination failure, shingles, welts, discomfort and pruritus to be possibly related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient age was in mid seventies. The patient had bad reaction to the shingles shot.  The patient had developed a mild case of shingles. The patient did not have pain, but welts, very uncomfortable, very itchy. This case was considered as suspected vaccination failure as details regarding full vaccination schedule, laboratory test confirmation and time to onset for the event was unknown at the time of reporting. The permission to follow up was denied.
I verified patient's DOB, phone number, address and vaccines VIA databases. I gave patient her vaccine consent so I started preparing vaccine. I prepared vaccine and verified patients name and symptoms. I spoke to patient and advice her with possible side effect. I did not checked for Expiration Date on vial because my supervisor picked up vaccines this morning from clinic and I though he had already checked this morning. Pt's left clinic after 15 min of observation. I was trying to document vaccine, and I added the vaccine but when I selected the correct lot number via data I then saw vaccines as ACTIVE and with the same lot # and it said we had 19 doses left in clinic. As I checked on data exp date was expired with a date of expiration of 6/12/2023. I right away called my supervisor to his work phone and asked him for expiration date and he saw that it was expired as well. He immediately spoke to his supervisor for further steps. My supervisor called patient as well to let her know of this situation.
still in fridge and expired/ 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point). At the time of the report, EXPIRED PRODUCT ADMINISTERED (still in fridge and expired/ 5 doses had been given at that point) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna vaccine was pulled from freezer on 16-DEC-2021. BUD date of 15-JAN-2022 was printed in red.  No concomitant medications were reported. No treatment medications were reported.
Swelling in armpit/lymph nodes; 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: ER8737), via an unspecified route of administration in the left arm on 01Apr2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. No concomitant medications were reported. 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 COVID-19 vaccination. On 03Apr2021, since 48 hours after the vaccination, the patient experienced swelling in the armpit/ lymph nodes. The event did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event swelling in the armpit/lymph node. The clinical outcome of the event swelling in the armpit/lymph nodes was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
COLIC ABDOMINAL PAIN; LIQUID STOOLS; NUMBNESS SENSATION IN THE LEFT ARM; HEADACHE; DIFFICULTY BREATHING; PAIN IN ARM; This spontaneous report received from a patient concerned a 28 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 02-MAY-2021, the subject experienced pain in arm. On 15-MAY-2021, the subject experienced difficulty breathing. On an unspecified date, the subject experienced colic abdominal pain, liquid stools, numbness sensation in the left arm, and headache. The action taken with covid-19 vaccine  was not applicable. The patient recovered from difficulty breathing, and the outcome of pain in arm, colic abdominal pain, liquid stools, headache and numbness sensation in the left arm was not reported. This report was non-serious.
bursitis, aches, and stiffness relieved with Advil 200 mg x 2 tab
Sudden, bilateral tinnitus. 12/9/2021: Four hours after receiving a Pfizer booster, I experienced sudden, bilateral tinnitus. It has not resolved and is quite loud. I have not yet sought medical treatment, but will if this continues. I had no other symptoms other than slight pain and soreness at injection sight.
Patient reschedule second dose scheduled for April 22nd and shared via email communication with vaccine clinic that she cancelled her appointment as she was feeling unwell and was diagnosed with shingles.  She stated "there was no rash, but extreme pain in the left side of my body. The pain began in my left arm, about ten days after receiving the first dose of the vaccine. It may have been just a coincidence, but I was very concerned about getting the second dose. "    The patient is planning to proceed with receiving her second dose
vaccine on 1/7 around 1130am. Onset of severe chills/shaking, fluctuating temperature (no fever), horrible aches and pains, significant fatigue, and persistent headache from about 3am the morning after (on 1/8) and lasting until bedtime that day. The next morning (1/9),  most symptoms had resolved except for fatigue. I also experienced a new sx: severe pain and tightness in my chest/torso; was hard to breath normally and could not take a deep breath without experiencing significant pain. This lasted until about 3pm. Fatigue persisted the rest of the day. All symptoms had resolved by the next morning (1/10).
Information has been received from a physician concerning a 90 year old female with chronic obstructive pulmonary disease, emphysema, hypertension, hyperlipidaemia, asthma and cough who on 26-JUL-2010 was vaccinated with first dose of PNEUMOVAX 23 (lot # not reported), 2.5 mL, intramuscularly. The patient was experiencing visions problems which might be pre-existing. The patient sought medical attention in office. At the time on the report the patient had not recovered. Additional information has been requested.
One day after vaccine, arm was sore and had bump. 3 days after, went to MD, told it was a knot and an allergic reaction, given 2 antibiotics. A week after vaccine, it was getting worse (huge "knot", red and painful) went back to MD and was sent to the ER. At ER, was told it was a staph infection - had I and D, given BACTRIM and clindamycin.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.         Concomitant medications included vitamins. Patient stated that she was taking Paxlovid for a couple of days and would like to know if Paxlovid interacts with the vitamins patient was taking. Patient wanted to know if vitamins were contraindicated with Paxlovid. Patient was scheduled to get a second booster. Patient wanted to know that can she get second booster, after being positive for COVID-19 and taking Paxlovid. No treatment medications were 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.
Patient was given flu vaccine at 1:15. She walked into lobby and became lightheaded. She began to shake, clenched her jaw and moan. Per her mother she was unresponsive for a few seconds she was seen by doctor 10 minutes later and diagnosed with a syncopal episode. No treatment necessary.
Breakthrough case admission after three vaccines  Moderna 1/9/21 Lot# 026L20A;  Moderna 2/6/21 Lot# 031L20A;  Moderna 12/11/21 Lot# 058H21A
I ended up at the hospital because of dehydration and  my heart was racing because of HL Fib. I also have severe nausea and headaches. The joint pain made me feel really bad. My Doctor became concerned because of my sever heart pains and he was the reasons that I went to the hospital.
Information has been received from a licensed practical nurse concerning a 55 year old male who on 16-JUL-2008 was vaccinated with PNEUMOVAX (lot # 658673/090U). On 16-JUL-2008 the patient experienced injection site soreness and injection site erythema. Subsequently, the patient recovered from injection site soreness and injection site erythema. The patient sought medical attention and contacted physician. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Chills; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, Heart rate increased: 140 (High) she experienced a fast heart beat. She said it got up to 140bpm..         No concomitant information was provided by the reporter.  No treatment information was provided.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. Approximately in 2015 (reported as "in June into July"), unspecified number of patients received unspecified doses of RECOMBIVAX HB (dose, route of administration, lot # and expiry date were not provided) that were improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recvd 2 doses of vax & w/in 1 hrs of 2nd dose exp occipital h/a described as a dull aching & throbbing; minimal relief from nuprin;
First break out in a rash, under my chin, on the side of my face my jaw on one side; headache; fever; muscle aches; chills; my Covid vaccines have all been Pfizer's Fine. I've had reactions; my Covid vaccines have all been Pfizer's Fine. I've had reactions; I was feeling ill; On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore; injection site pain; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side) and HEADACHE (headache) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 203g23a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included PARACETAMOL (TYLENOL) for Fever and Pain.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 12-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (injection site pain). On an unknown date, the patient experienced ILLNESS (I was feeling ill), PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever), MYALGIA (muscle aches), CHILLS (chills), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions). At the time of the report, ILLNESS (I was feeling ill), INJECTION SITE PAIN (injection site pain), RASH (First break out in a rash, under my chin, on the side of my face my jaw on one side), HEADACHE (headache), PYREXIA (fever) and MYALGIA (muscle aches) had not resolved, PERIPHERAL SWELLING (On Monday my arm was Hard and swollen. It's still swollen, but it's not hot anymore), INTERCHANGE OF VACCINE PRODUCTS (my Covid vaccines have all been Pfizer's Fine. I've had reactions) and COVID-19 IMMUNISATION (my Covid vaccines have all been Pfizer's Fine. I've had reactions) outcome was unknown and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. The rash on patient's face went away and it's just now the one on the arm.
VARICELLA ZOSTER VIRUS MENINGITIS; ACHES; RIGHT LEG (L5 DERMATOME) INVOLVEMENT WITH VESICULAR SKIN LESIONS; FEVER; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) was received on 23-Jul-2021 and concerned a 34-year-old female with unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no past medical history.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: Unknown) dose not reported, 1 total, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was reported that 2 weeks after vaccination on an unspecified date, the patient experienced significant immunological response like fever and ache to the vaccine. On an unspecified date, the patient had right leg (L5 dermatome) involvement with vesicular skin lesions and headache with eventual diagnosis of varicella zoster virus meningitis (VZV meningitis). Laboratory data (dates unspecified) included: Absolute lymphocyte count (NR: not provided) Normal, and HIV antigen (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, aches, varicella zoster virus meningitis and right leg (l5 dermatome) involvement with vesicular skin lesions was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210756694-covid-19 vaccine ad26.cov2-varicella zoster virus meningitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Halfway down both legs below the knees had red welts that scratched so bad, i could have scratched it down to the bone. In the crook of the right arm, I had blisters that had skin peeling off and it burned so bad.
This spontaneous report as received from a registered nurse via a company representative concerning a female patient. Two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (dose, duration and indications were not provided). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a female patient of unknown age. She was vaccinated with a dose of Hepatitis B vaccine (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B vaccine (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.
This spontaneous report was received from registered nurse referring to her daughter a female patient of 4 months old. The patient did not have pertinent medical history, drug reactions or allergies. No laboratories were performed. On 05-DEC-2017 the patient was vaccinated with the first dose of ROTATEQ, orally for prophylaxis (dose, frequency, lot number and expiration date were not reported). No side effects were reported after getting the first dose. Approximately on 14-FEB-2018 the patient was vaccinated with the second dose of ROTATEQ, orally for prophylaxis (dose, frequency, lot number and expiration date were not reported) and immediately after getting the second dose experienced "diarrhea and constipation". The mother stated that on the night she received the vaccination, and a few days ago, she also had a low grade fever  which she thought might be related to the ROTATEQ and furthermore on an unspecified date in 2018, the patient developed "a little redness on her cheeks near her lips and red patches around her chest." The mother also noted that her daughter was vaccinated concomitantly with "3 or 4 other vaccines" (product names unspecified) the same day she was administered with ROTATEQ as well. The mother said she was concerned that her daughter's symptoms had continued on since administration of the vaccine 3 weeks ago. No treatment was given for the adverse events, and no laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The outcome of the events was reported as not recovered. Causality assessment for Erythema, Diarrhoea and Constipation was not provided.
Woke up today (04/19/2019) with hives/itchiness on head, abdomen, ankles.
I had my first shot around 10 am and my left arm was very sore and got progressively worse.  I played golf the next day (Tuesday) and I woke up in the middle of the night with nagging shoulder and chest pain.  I was concerned it was heart related.  It continued for 2 weeks off and on but fairly intense at times.  Not sure if I slept on it funny.  When to my primary care dr and had an X-ray and ekg.  Both came back negative.  I am still having chest pain so I am calling again 3/22 to discuss with dr.
Staff member received TD instead of PPD to LFA Intrathecally which resulted in moderate induration lasting approx 10 days.
Information has been received from a 42 year old white female consumer with a history of a food allergy, sulfur allergy and allergy to Levaquin who on 11/10/03 at 3:00pm, was vaccinated SC in the right (also reported as IM) with a 0.5mL first dose of pneumococcal 23v polysaccharide vaccine (Lot # 646159/0287N). Concomitant therapy included fluvoxamine maleate (Luvox), levothyroxine Na (Synthroid) and ethinyl estradiol/norgestimate (Ortho Tri-cyclen). There was no illness at the time of vaccination. Within 48 hours the pt experienced hives (also reported as prickly spots). The pt reported that she is being treated with Benadryl for the hives. Medical attention was sought. It was unknown if labs or diagnostics were done. It was reported that the pt was recovering with sequelae.  No product quality complaint was involved. Follow up information received from the physician indicated that the pt did not come in for a office visit. She reported to the physician that she had prickly spots all over. There were no labs or diagnostic tests done. It was reported that the pt recovered. Additional information is not expected.