chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BODY ACHES (MUSCLES, BONES AND  JOINTS); HEADACHE; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 13:30 for prophylactic vaccination. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the subject experienced body aches (muscles, bones and joints), headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches (muscles, bones and joints), and fever, and headache on 09-APR-2021. This report was non-serious.
Patient given bivalent 50 mcg  instead of monovalent 00 mcg for 2nd dose in series. Attempting to contact patient to schedule monovalent dose.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. No pertinent medical history and concurrent conditions of the patient were reported. On 07-SEP-2015, the unspecified patient was vaccinated with ZOSTAVAX vial (Lo021609 and expiry date: 10-SEP-2016) (dose, site and route of administration not reported). On 08-SEP-2015, the patient woke up in the morning and noticed a "golf ball sized" swelling and injection site reaction. The patient was advised to ice the area. No laboratory details were provided. The patient sought for the medical attention and called the pharmacist. The outcome of injection site swelling and injection site erythema was unknown. The causality of the events was not reported. No product quality complaint (PQC) was filed. No further information was available. Additional information has been requested.
Initial report reported by physician on 26-Nov-2013: A unknown age of male patient, medical history and concomitant medical history was unknown , received dose of FLUZONE at unknown anatomical site on unspecified date. It was reported that patient experienced sever deltoid pain after 7 days after receiving vaccination. Event outcome was unknown. List of documents held by sender: none.
The day after the injection she noticed swelling in her right axilla that is painful but no redness. She also had one day of headache, chills and joint pain.
About five hours after I got the third dose of the vaccine, I experienced blisters in my mouth. My whole mouth was raw. I also got blisters in my mouth after the first dose of my vaccine. The blisters have been present for the ten months and I have had to eat a soft diet. It has been a month and I still have some blisters on my lips that are big. The blisters are very painful especially on the tip of my tongue and up on my palate. I use Orajel and some gentian violet purple dye to relieve the pain in my mouth. That night I developed a fever, and I woke up with a massive migraine. My migraines have been worse since I got the first and second dose of the vaccine. I used to get migraines all the time, but the pain was more manageable. Now I take another medication for my migraines. They have eased a little in the month since I got my third dose and I have missed some work. All of the side effects that I had after my first doe of the vaccine became worse after the third dose. I also developed a swollen lymph node under my left arm.
Mom reports episodes of "shaking" after 2 mo & 4 mo IMZ received. Seen by hosp - r/o seizures. No findings.
The first two days I had fatigue, chills, and fever of 101. I took a COVID-19 test and it was positive. The third day I started coughing and congestion in my lungs. I talked to my doctor, and they prescribed me Paxlovid. I was positive for 11 days. I think I have an after effect from COVID-19. I started to get fluid in my left ear and crackly sounds. I went to the doctor and he said to take nasal spray and it has not goes away. I might have to get a little surgery on my ear because its not clearing on its own.
It started with the pneumonia vaccine and then the 2 covid vaccines and I lost all my hair; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced it started with the pneumonia vaccine and then the 2 covid vaccines and i lost all my hair (alopecia) on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Patient states history of PEG allergen which causes her "heart to buzz" . Complains of heart buzzing initially  lasting 10 min before resolving;  Vitals @11:22am 73bpm, BP 122/60 O2 99% RA. Patient is stable
This spontaneous report was received from a physician via company representative and refers to a 16-year-old female patient. The patient's pertinent medical history, drug reactions, allergies and information about concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with the GARDASIL 9, 0.5 ml, intramuscularly (lot # and expiration date were not reported) for prevention of Human Papillomavirus. On 04-OCT-2017, the patient was vaccinated with second dose of GARDASIL 9, 0.5 ml, intramuscularly (lot # reported as N016832, expiration date were not reported) for prevention of Human Papillomavirus. On 04-OCT-2017, the patient experienced cold hands and cold feet. The patient had to be picked up from school. The patient sought a medical attention, she contacted the physician's office. No laboratory diagnostic studies were performed. No treatment was given for the adverse events. The patient recovered from the adverse event on an unknown date, approximately in October 2017. The relatedness between the adverse event and GARDASIL 9 was not reported. Lot number N016832 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast).
COVID-19; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 06-Dec-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   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.
Headache, Myalgia, Arthralgia, PAIN, REDNESS, SWELLING IN ARM AND  FATIGUE Narrative:
Left Axillary Lymph Node  Edema - approximate side of a golf ball - Less than 24 after receiving the 2nd dose of the vaccine.  Along with extreme fatigue, mild body aches and fever temp of 100.4 - which lasted for about 48 hours except for the enlarged lymph node which lasted about 5-6 day - I treated this using warm compress and  650mg of  Tylenol  2-3 time a day for the first 3 days.
7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date). On 03-Jan-2022, EXPIRED PRODUCT ADMINISTERED (7 booster doses of the Moderna Covid-19 Vaccine given on 3Jan2022 were past the 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. No Treatment information was reported. Date the vial was initially stored in the refrigerator was 1 Dec 2021 and the vial undergone any temperature excursions and the dose were past the 30-day Use By Date of 30Dec2021.
She received J&J COVID vaccine on April 5 around 11:45 AM.  That day afternoon she started noticing generalized headache acute onset and was continuously present for following 4 to 5 days.  She had 1 day of headache free symptom.  And she started noticing fluctuating intermittent headaches since that time until today.  She still has headaches ongoing today.  A week ago she also started noticing nausea which is been ongoing and blames mostly for headache.  It is intermittent and denies any vomiting.  No abdominal cramps diarrhea or constipation or blood in stool.  She also started noticing dizziness 5 days ago which was more intense and frequent at that time but for the last 2 to 3 days it has become in less frequent.  She walked to the clinic today for the fear of driving and dizziness.  Denies any blurry vision but does have photophobia.  She also complains about loss of appetite but she mentions it is coming back today.
Tinnitus, to the point of being unable to sleep. GP referred me to the ENT for a hearing test. Hearing test revealed significantly reduced hearing, altho the last test was several years ago. Stapedectomy of one ear; that ear lost the most hearing.  Tinnitus continues to worsen. Asked about whether CPAP (sleep apnea) would affect the tinnitus, and verdict from both ENT and Sleep specialist was that did not. No reaction from either doctor on whether the vaccine impacted the tinnitus.
large upper body rash and rash on her neck; rash at the injection site; This case was reported by a pharmacist via sales rep and described the occurrence of injection site rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received Shingrix. On 14th March 2020, 2 days after receiving Shingrix, the patient experienced itchy rash. In March 2020, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash and itchy rash were unknown.   It was unknown if the reporter considered the injection site rash and itchy rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient who got the shingrix vaccine 3 days ago. 2 days in she presented with a rash at the injection site. On the day of reporting, she presented with a large upper body rash and rash on her neck that itches. The reporter referred the patient to the physician and asked if this was a normal reaction.
Patient tested positive for COVID-19 after vaccination with symptoms of shortness of breath, fever, sore throat, and loss of appetite followed by shortness of breath and cough. She was diagnosed with pneumonia and treated with remdesivir 200 mg IV x 1 followed by 100 mg IV x 4 additional days, dexamethasone 6 mg PO daily (has received 8 of 10 days so far), and started on 2L of oxygen by nasal cannula which escalated to 3L, which she is still receiving. She is also enrolled in the GIGA 2050 study. She is gradually improving clinically. Liver and renal function have been normal and stable.
Pt received two doses of Engerix B vaccine. 1st Dec 2001 and Jan 2002. With labs drawn in February a positive Hbsag status was noted-this was previously negative. It was repeated and remained positive up to the time pt expired on 05/28/02. LFT's also increased with May's labs.
Swollen upper leg. Red and itchy, warm to touch. Began within hours of vaccine. Now end of day 4 and is still itchy and red.
Information has been received from a health professional concerning a 72 year old female with an allergy to "Ketek" who on 30-JAN-2007 was vaccinated SC with a dose of Zostavax 9lot # 652936/0981F). Concomitant therapy included calcium (unspecified).On 31-JAN-2007 the patient developed redness, slight swelling, soreness and hotness around the injection site. The area was about the size of two half dollars. The patient was scheduled to have an appointment on 06-FEB-2007. The patient reported that the area has not improved other than a decrease in soreness. No laboratory tests were performed. There was no product quality complaint involved. Additional information has been requested.
16 hours after injection moderate pain in entire arm.  Pain made sleeping difficult.  Difficulty lifting arm above heart due to pain.  Treated with OTC ibprofen 200 mg.  28 h low fever and lower back pain.  Treated with OTC tylenol.  40 after injection sever pain in arm.  Pain radiating down to fingertips.  Too painful to sleep.  Difficulty using arm due to pain.  Treated with double OTC ibprofen dosage every 4 to 6 hours.  Low fever persisted.  At 58 hours fever is gone and pain is mild, still using OTC ibprofen at recomended dosage.
Patient came to facility for 2nd dose of Pfizer. Patient reported she felt woozy one hour after her 1st dose. Patient reported she took Tylenol and symptom went away.
6 hours later urticarial rash all over gave Benadryl PO.
Arm was very sore starting immediately.  Approximately 6 hours later started getting chills.  Had chills, fever, very sore arm, headache, fatigue, aches and pains starting the Saturday night (got the vaccine Saturday afternoon about 2pm).  The fever and chills went away after 2 full days.  Still had a sore arm and fatigue for 3 full days after - so 5 days of fatigue and sore arm.
Swelling of nose and upper lip; rash on face, arms, chest, legs, feet.; Headache; general aching all over body; Swelling of nose and upper lip; low grade fever; This is spontaneous report received from a contactable consumer (patient). A 70-years-old female non- pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6207) via an unspecified route of administration on 18Mar2021 at 10:00 am on left arm as a single dose for COVID-19 immunization. Medical history included diabetes. Patient had no allergies to medications, food, or other products. Concomitant medications were not reported.  Patient received other medications within 2 weeks of vaccination. Previously, she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810) via an unspecified route of administration on 15Feb2021 at 02:00 pm on left arm as a single dose for COVID-19 immunization. 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 vaccination. The patient was not tested for COVID-19 since the vaccination. On 18Mar2021 patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Doctor's office/urgent care. On 18Mar2021 at 04:00 pm, patient experienced swelling of nose and upper lip, headache, low grade fever, general aching all over body and rash on face, arms, chest, legs and feet. Treatment was received for the adverse event. Outcome of the events was recovered.  No follow-up attempts are needed. No further information is expected.
Syringe leak - 1 drop down arm.  Patient received more than 50% dose, did not repeat dose.
This spontaneous report was received from an Office Manager referring to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not provided. On 15-JUN-2017, the patient was vaccinated with an improperly storage dose of PROQUAD (dose and route were not reported) lot number N002915, expiration date 24-JUL-2018. The temperature excursion was from -14 degrees Celsius to -10 degrees Celsius for 390 hours, 55 minutes and in the range -9 degrees Celsius to 8 degrees Celsius (-1C) for 5 minutes (Digital Data Logger). There was no previous temperature excursion. The office manager stated that all vaccines were reconstituted with sterile water diluent that did not undergo a temperature excursion. No adverse effects were reported. This is one of six cases reported by the same source (Linked reports MARRS # 1706USA010254, 1707USA000678, 1707USA000679, 1707USA000680, 1707USA000681). Sender's Comments: US-009507513-1706USA010254: US-009507513-1707USA000678: US-009507513-1707USA000679: US-009507513-1707USA000680: US-009507513-1707USA000681.
After having patient to wait 15-20 minutes before leaving, she complained of feeling dizzy. She fainted briefly. The provider reassessed her found no injuries. No treatment required.
Felt palpitations; Blood pressure started to rise 180 over 107; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Felt palpitations) and BLOOD PRESSURE INCREASED (Blood pressure started to rise 180 over 107) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Sleep disorder NOS. Concomitant products included CARVEDILOL for Blood pressure high, HYDROXYZINE HCL for Sleep disorder NOS, ATORVASTATIN, CALCIUM CARBONATE (OS CAL [CALCIUM CARBONATE]), VITAMIN D3 and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PALPITATIONS (Felt palpitations). 16-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure started to rise 180 over 107). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Felt palpitations) and BLOOD PRESSURE INCREASED (Blood pressure started to rise 180 over 107) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 180 over 107 (Inconclusive) started to rise.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reportedly, two hours after the vaccination, patient's blood pressure started to rise 180 over 107. Then she took a deep breath, and it went down a little but then went back up again. She took paracetamol and in the evening she took her blood pressure medicine.
Presented with SOB x 2 days, hypoxic; + covid 5 days PTA; Admit 9/22 to medical with  Covid PNA; tx with 9/22 Rocephin, steroids, zinc, Vit C, azithromycin, pulmicort,  lovenox, singulair, 9/23 Baricitinib, Remdesivir, Vit d3,  O2 requirements: Initially NRB with HF O2; down to NC 10/3; low dose O2 at d/c
Suspected vaccination failure; Got Shingles; Still have nerve pain; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient reported that, he/she had the Shingles shot and still got shingles and still experienced nerve pain, it's been 2 years. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
pt recvd vax; generalized urticaria 11 days post vax; angiodema devel day 12; swelling of eyes, lips, hands & feet; tx w/ dph, glucocorticoids & soluMedrol; resolving as of 16feb94;
Received Pneumovax immunization in right deltoid IM on 12-06-2007.  Within 24 hrs. patient has cellulitis , swelling, erythema, painful to move arm below injection site.  T=99.6 po.  Tx: rest, elevation, alternate ice/heat, Aleve BID for discomfort, Benadryl liquid as directed and Keflex QID x7 days.
Influenza/Prevnar shot given 3/5/08; prt reported temp of 104.8 and seizures next day- taken to ER. F/u with pediatrician on 3/7/08.
10:00, nurse practitioner at clinic phoned to inquire about side effects of Hep A vaccine as pt had presented this AM with nausea, sinus congestion and "rash" that looked like "little bites" Right forearm. Mother states child c/o chest discomfort; went back to school after evaluation no temp, per mother's history.
Fainting and ringing in ears after 1 day per pt dad. Referred to otolaryngology for eval and treatment.
This is a spontaneous report from a contactable consumer. A 58-years-old female patient received PREVNAR 13, via an unspecified route of administration in the left arm on 17Sep2015 at single dose. The patient medical history and concomitant medications were not reported. The patient could not move arm and as they were giving it to her the pain hurt so bad all the way on 17Sep2015 with outcome of not recovered; frozen shoulder on an unspecified date with outcome of  unknown. Reporter stated that she went to her doctor for a checkup and received PREVNAR 13. As they were giving it on 17Sep2015 the pain hurt so bad all the way to her wrist. Stated she can't move her left arm. She has been to an orthopedist, physical therapy and is now seeing a chiropractor. The pain and not being able to move her arm were noticed immediately after the vaccine and have both gotten worse. She stated that she does not want to receive the product again. On 28Oct2015 her primary care provider told her she had a frozen shoulder and treated it with steroids.