chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the mother of an 18 year old female with no history of cold sores and no known drug reactions or allergic reactions, who on 29-MAR-2007, was vaccinated with GARDASIL. Concomitant therapy included YASMIN for birth control. On approximately 22-MAR-2007, the patient received her first of 5 weekly doses of anti-malarial medication (not further specified) in preparation for a trip to another country. On approximately 31-MAR-2007 the patient developed a cold sore on her upper lip. The cold sores progressed to "a cluster of ugly cold sores" on her upper lip. The cold sores went away on approximately 07-APR-2007. Some scarring remained on her upper lip. On 24-MAY-2007, the patient received her second vaccination of GARDASIL. On approximately 31-MAY-2007 the patient broke out with cold sores in the same area of the upper lip as previously. The patient was not pregnant and not hospitalized. Additional information is expected. 10/08/07 This is in follow-up to report(s) previously submitted on 7/6/2007. Information has been received from the mother of an 18 year old female with no history of cold sores and no known drug reactions or allergic reactions, who on 29-MAR-2007, was vaccinated intramuscularly with a first dose of GARDASIL (Lot # "02340"). Concomitant therapy included YASMIN for birth control and ACCUTANE. In addition, it was noted that approximately 1 week prior to her first GARDASIL vaccination, the patient began taking an anti-malarial medication (not further specified) in preparation for a trip to another country. She took the medicine once per week for five weeks. Approximately two to three days later after vaccination with GARDASIL, the patient developed a cold sore on her upper lip. The cold sore progressed to "a cluster of ugly cold sores" on her upper lip. The cold sores went away after approximately seven to ten days. Some scarring remained on her upper lip. On 24-MAY-2007, the patient was vaccinated intramuscularly with her second dose of GARDASIL (Lot #657737/0523U). Approximately one week later, the patient again broke out with cold sores in the same area of the upper lip as previously. The patient contacted the physician's office on 05-APR-2007 and 04-JUN-2007. The patient was not pregnant and was not hospitalized. At the time of this report, the patient had recovered. No product quality complaint was involved. Additional information is not expected.
This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Indigestion), FLATULENCE (gas), PYREXIA (fever 100.4), CHILLS (cold chills) and MYALGIA (arm is very sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13M2DA and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HCTZ and AMLODIPINE for an unknown indication.   On 11-Feb-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) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DYSPEPSIA (Indigestion), FLATULENCE (gas), PYREXIA (fever 100.4), CHILLS (cold chills) and MYALGIA (arm is very sore). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DYSPEPSIA (Indigestion), FLATULENCE (gas), PYREXIA (fever 100.4), CHILLS (cold chills), MYALGIA (arm is very sore) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Body temperature: 100.4 (High) had to go to ER last night due to fever 100.4. On 12-Feb-2021, Body temperature: 99.4 (High) Temperature is 99.4, took just before calling to customer care..         Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Significant follow up Event Headache was Received
1/30/21: "whoosh-like" dizzy spell and nauseous at 8AM, okay during the rest of the day, then very dizzy, nauseous (vomiting with the dizziness at 10 PM for about one hour), continued dizziness and nausea throughout the night and through the next day  1/31/21: continued light dizziness and light nausea throughout the day (rested at home) -- a bit weak and a bit fatigued 2/1/21 - 2/2/21: light-headed, a bit woozy, a bit weak, and a bit fatigued (rested at home) 2/3/21 - 2/4/21: feeling much better but still a tiny bit woozy/light-headed (resumed normal activities but careful about balance)
Acute respiratory distress, airway compromise, fever, rash (neck, arms, front, back, abd., face), malaise
Rash/hives post 2 hours.  Benadryl IM 50mg, allegra 60 mg tab per mouth 3 times a day as needed.
daptacel vaccine was given 4 days past the expiration with no reported adverse event; Initial information was received on 28-Jun-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old male patient to whom diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] was given 4 days past the expiration with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Jun-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine (Suspension for injection) (lot C5893AA, expiry date: 21-Jun-2023, strength: standard) via intramuscular route in right thigh for Immunization.  On 26-Jun-2023 the patient had daptacel vaccine past the expiration with no reported adverse event (expired product administered) (Latency: same day) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 guidelines. 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.
she had pressure headaches; she had pressure headaches and it extends to the back of her head and neck; she had pressure headaches and it extends to the back of her head and neck; This is a spontaneous report from a contactable Other HCP(patient). A 37-year-old female patient received BNT162B2 (lot number E13246) , Intramuscular at Arm Left on 07Jan2021 09:30 at the 37 years old at single dose for COVID-19 immunization. The medical history included Shellfish allergy. The concomitant medications were none. Since taking the vaccine on Thursday morning, starting Friday morning on 08Jan2021 she had pressure headaches and it extends to the back of my head and neck. There was no treatment received for all the adverse events. There was no other vaccine in four weeks. There was no covid prior vaccination. The outcome of the event was not recovered.
Low grade fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 29Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Low grade fever"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Headache".  Additional information: Reporter stated, her husband received the Pfizer vaccine yesterday morning and experienced adverse event. She asked what type of pain medicine that she can give him for the headache?. In response for further probing: Reporter stated, What type of Questions? Reporter was informed and provided with the number of Pfizer medical information department. For LOT# , Reporter stated, No, If you can't answer her question. She was not staying on the phone. Reporter was unwilling to complete the report so no further probing was done. Hence limited information was available over the call.  Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. .
2 days after injection I had a red, itchy arm pit on the same arm as the shot.  Lasted a day, felt itchy all over, pretty mild.  It went away that same day.  Then 10 days after the shot I had a red rash at the injection site about 3 inches across.  It didn't itch, I was surprised to even see it.  Rash went away by the next morning so I never got a picture of it.   This was a mild reaction, in my unprofessional opinion.....I'm just concerned I'll have a bigger reaction to the 2nd shot and wanted it recorded that there was an issue with the first one.
Inflammation that can be felt and seen on left upper abdomen accompanied by constant dull pain. Two small soft lumps can be felt in the area.
This spontaneous report was received from a registered nurse via company representative refers to a female patient of unknown age. No medical history was reported. On 14-MAY-2013, the patient was vaccinated with an expired dose of GARDASIL (lot # 668262/0841AA, expiry date 08-APR-2013) 0.5 ml, first dose, unknown route. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Tenderness, redness, warmth, and the feeling of a knot under the skin on the left deltoid.
fatigue first day, by 2nd-3rd day sore with body aches and left side foot, knee, hip pains and shooting pains up and down back of neck. Went to drs office on 4/12 and discovered swollen lymph nodes. Head aches every day since vaccine.
Patient developed an irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Patient developed an irregular heartbeat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. In May 2021, the patient experienced ARRHYTHMIA (Patient developed an irregular heartbeat) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Patient developed an irregular heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate: irregular (abnormal) irregular.         The concomitant medications were not reported. The treatment information was not provided.   The patient developed irregular heart beat around May 2021 post vaccination.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Multiple co-morbidities history of COVID-19 6/8/2020 and 12/28/2020.  At time of vaccination fighting osteomyelitis.  1st dose 1/13/21, 2nd dose 2/3/2021 expired 2/8/2021.
Copious cold sweats for hours each day - still persists Fatigue Nausea Elevated BP and HR Incredible lower leg, foot pain. Insomnia Constipation Various tics and nerve pain
Pt recvd vax on 21APR93 & exp a h/a & a local react manifested by redness, swelling, heat & soreness; subsequently recovered; No further details were provided;
Pain started in hands and wrists and went up my forearms, then my neck and head. Eventually I could not turn my head and had a terrible headache. My knees started swelling and there was a lot of pain in my right knee especially. I eventually swelled to the point I could not stand or bear weight and ended up in the hospital emergency department.  I had been to my pcp about my symptoms and was diagnosed with systemic lupus and rheumatoid arthritis. Then started having flares and was treated with steroids and other anti inflammatory medications.
After injection, pt could feel the pain spreading around the site, and reports an overall sore muscle pain with difficulty moving left arm that night (no redness). Next morning, she noticed redness and swelling that was band-like toward the back of the arm and below the site of injection. It began to feel better through the day but that night she realized the redness had moved down on her arm. When pt presented 3 days later, her arm was red, hot, swollen and blotchy (further down from the site of injection). The actual site looked normal, but pt says it was still a little sore underneath and she feels like the soreness was following her muscle down the arm. She states the pain today is not as sore as it previously was.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 52-year-old male patient who received SHINGRIX. On 14th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th February 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. On 15th February 2018, the patient experienced injection site pain and shivering. On an unknown date, the outcome of the injection site pain and shivering were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the injection site pain and shivering to be related to SHINGRIX. Additional details were provided as follows: The patient was about 52 years old, but the sales representative did not know the exact year of his birth. At 15:00, the patient was administered SHINGRIX vaccine on an unknown arm in the tricep instead of the deltoid, which led to vaccine administered at inappropriate site. One day after receiving vaccination, the patient stated that his tricep was really, really sore and he was experiencing some shivering. The patient was told by his pharmacy to come back in 1 month for the 2nd dose of SHINGRIX.
No Signs or symptoms to report. Varicella and MMR were given as IM in Error.
It was like mild lower back pain like on the lower left part of my back on top of my buttocks; Pain just seems to be getting worse; Dizziness/Lightheaded; Headache; This is a spontaneous report from a contactable healthcare professional. A 59-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Covid 19 Vaccine; lot number: EL3246; expiration date: unknown), via an unspecified route of administration left upper arm on 30Dec2020 11:30 AM at a single dose for Covid-19 vaccination. The patient has no medical history and concomitant medications. The patient reported that she got her first dose of Pfizer vaccine (COVID-19 Vaccine) yesterday (30Dec2020) and today (31Dec2020), she was having at first it was like mild lower back pain like on the lower left part of her back, on top of her buttocks and now it's getting worse. The patient inquired if it was like a side effect. The patient further stated that yesterday  (30Dec2020), she had a side effects like the dizziness, lightheaded and the headache and that went away after she took Tylenol (treatment) but then today this pain just seems to be getting worse. The paracetamol (TYLENOL) was given to her at hospital yesterday for the headache and the dizziness. She hasn't taken anything today because she was not sure if it is okay for her to take Ibuprofen which is what she would prefer to take. She received her COVID-19 Vaccine at a hospital. The outcome of the events was not recovered.
Patient missed her second dose and now it has been >42 days that she still hasn't received her second dose; A spontaneous report was received from a other health professional concerning a 55-years-old female patient, who received Moderna's covid-19 vaccine (mRNA -1273) and missed her second dose(inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant medications were not reported.  On 18 JAN 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20H(?)) intramuscularly for prophylaxis of COVID-19 infection.    On 18 JAN 2021, the patient received the mRNA-1273 vaccine and missed her second dose now it has been more than 42 days that she still hasn't received her second dose. Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event missed second dose was considered to be resolved.; Reporter's Comments: This report refers to a 55-years-old female patient who missed her second dose and now it has been >42 days that she still hasn't received her second dose (product dose omission) for mRNA-1273. There were no reported AEs associated with this case of product dose omission.
Severe, debilitating lower back pain 10/10 level pain  OTC pain meds provide zero relief  Barely able to walk Began less than 12 hours after vaccination  3 days later, pain level is still 10/10
began day after vaccination administration with fever, headache, body aches and generalized itching. Progressed over next 5 days with same symptoms plus rash which is still evolving. The rash is now on b/l arms, right leg, right upper chest and left neck. It looks herpetic with macular erythematous patches with vesicles.
I felt a little "high".  It felt similar to the side effect of IV steroids.  I had a little bit of a hard time thinking/processing.  This lasted at least an hour, maybe an hour and a half.
Patient did not experience adverse effect, this is a report of an error in administration of vaccine. Patient is under 18 years old received Moderna Vaccine. At the time of vaccination it was understood that anyone 16 and older could receive Moderna. Since it was pointed out that it is not the case, our facility stopped vaccinating 16 to 18 year olds with Moderna.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 02-SEP-2016, the patient was vaccinated with  an expired dose of PROQUAD (Concentration, dose and route of administration were not reported), lot # L006388, expiration date 25-AUG-2016. Patient's concomitant medication was not provided. No adverse effect was reported. A product quality complaint (PQC) was not involved. Additional information has been requested.
3/4/23 I was working out at the gym and had to go to the bathroom and had diarrhea. For the rest of the day, I could not eat anything. I started drinking Pedialyte. On 3/6/23 I woke up nauseous and vomited. The main symptoms for several days were nausea, occasional vomiting and diarrhea. On 3/7/23 I tested positive with an at home COVID test. On 3/8/23, I had a telehealth appointment and was prescribed PAXLOVID and began taking it that day. On 3/9/23 I began having a stuffy head, congestion and flu symptoms. I no longer had nausea, vomiting or diarrhea. I got a really bad sore throat and a cough. I was taking over the counter medications along with the PAXLOVID. On 3/11/23, I felt better. I still had a cough and a little bit of a sore throat. I felt progressively felt better every day throughout the next week. The cough lingered until the end of the month.
Child developed a large, orange-sized reddened area in thigh, post vax. Redness began approximately 24 hours after injection and described as red, hot, firm to touch. 48 hours later, continued to be pink, warm to touch. No other symptoms presently. On the night of the shot, had a low-grade fever but currently has no fever. Mother was informed that 2 other children at that clinic had developed similar symptoms but progressed to cellulitis. Mother was advised to consult PMD. The child was placed on Keflex.
Chills; preventing the patient from working; Myalgias; Severe fever; This is a spontaneous report from a contactable physician.  The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 02Mar2021, this case now contains all required information to be considered valid.    A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced severe fever for 48 hours, chills, and myalgias preventing the patient from working. The patient recovered from severe fever, however the outcome of the other events was not specified.  According to the reporting physician the above described events were related to BNT162b2 vaccination.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
patient received two doses of Adacel one on 16aug2023 and on 10July 2019,less than 10 years apart with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 year old female patient who received two doses of diphtheria-2/tetanus/5 AC Pertussis Vaccine [Adacel] one on 16aug2023 and on 10july 2019,less than 10 years apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jul-2019, the patient received a unknown (dose 1) dose of suspect diphtheria-2/tetanus/5 AC Pertussis Vaccine (strength, expiry date and lot number not reported) via unknown route in unknown administration site; On 16-Aug-2023 she also received a dose 2 at dose of 0.5 ml of the same vaccine (strength: standard, frequency: once, expiry date: 18-Aug-2025 and lot U7869AA) via intramuscular route in the left deltoid for immunization. Information on the batch number was requested.  On 16-Aug-2023 the patient received two doses of adacel with in less than 10 years apart with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 guidelines. 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.
Patient complained of light headedness and heart racing on and on 15 minutes after vaccination shot as if she had consumed  a lot of red bull energy drinks.
Increased swelling, warmth and redness at injection site. Erythema 5 1/2 X 3 1/2  with 4cm X 2 1/2cm wheal local reaction only. Pt reports itching at injection site. Denies SOB or systemic symptoms.
On 10/23/00 at 17:15, doctor received a phone call from ER stating baby brought in. Found in bed, already had some rigor/cyanosis; coded but pronounced dead. Autopsy states the cause of death as interstitial pneumonitis. Also states baby girl was found unresponsive in her play pen, lung congestion
Fever, chills, debilitating fatigue for 3 days, with fatigue continuing for additional 3 days.