chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at the injection site; increased pain on his right hip and buttocks / HCP asked what / pain level was prior to / injecting / replied a SIX; increased pain on his right hip and buttocks / About 14 hours after receiving / Vaccine pain moved to / left buttocks / HCP asked what / pain level was prior to / injecting / replied a SIX; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old male patient who received Herpes zoster (Shingrix) (batch number EG3A3, expiry date 31st December 2021) for prophylaxis.   Concurrent medical conditions included low back pain. Concomitant products included gabapentin.   On 17th June 2021 14:00, the patient received the 1st dose of Shingrix (intramuscular). On 17th June 2021, 4 hrs after receiving Shingrix, the patient experienced injection site pain, pain in hip and buttock pain. The patient was treated with diclofenac (Diclofenac Patch) and paracetamol (Tylenol Arthritis Strength). On an unknown date, the outcome of the injection site pain, pain in hip and buttock pain were recovering/resolving.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the pain in hip and buttock pain to be related to Shingrix.  Additional details provided were as follows: Patient himself is the reporter. Patient received his first Shingrix vaccine,after 4 hours later he experienced soreness at the injection site, increased pain on his right hip and buttocks.About 14 hours after receiving his first Shingrix Vaccine the pain moved to his left buttocks. Patient reported that he is scheduled to receive an epidural late next week for his back pain which was unrelated to the Shingrix vaccine. The patient reported that the Health care professional had asked about what his pain level was prior to her injecting the Shingrix vaccine and he replied a six. Patient reported that his adverse events was better since he used a Diclofenac pain patch and Arthritis strength Tylenol. Patient did not given permission to contact the health care professional. Reporter did not consented to follow-up.
rt arm deltoid region noticeable redness, fever-hot to touch, dark red center around inj site;hard knot formed;pt recv tx w/steroid & ATB therapy;site looks well as of 20JUL98;small knot remains in area;
left arm mobility -could not lift Armand movement limited for 3 days-then got 95% better but then about 1 week later same issue with left arm-limited lifting ability and movement-after 3-4 days called my doctor who told me to take Tylenol, has helped and I am about 96% normal s of ti date 2/15-  **question --is it recommended for my second shot 2/22 to be given in left arm?
The next day after the shot, less than 24hrs, allergic type reaction. Hives all over face, neck, back, chest. Red itchy face. Treated with Benadryl and ibuprofen. Intensity lasted for several days and then slowly resolved over a week.
Patient received an unapproved booster dose mistakenly since the minimum age approved is 16 years old and the patient is 14 years old. Patient is not experiencing any unusual adverse events.
After left arm was down for a period, not easily able to pull up without hurting.  Achy feeling up to shoulder and down pass elbow. Trouble sleeping at night if arm is left in permanent position.
Rash/Dry Scaly Red spot on Right shoulder. About the size of a quarter.  Itchy Rash on abdomen and back.
One hour after vaccination had warm feeling all over face, not flush and did not have fever. Lasted all night long and patient was also nauseous. She then stated she had numbness along left jaw, this happened hours after vaccination. The next day she felt better, nurse told her if it happens again or doesn't resolve follow up with PCP. The following day, associate felt better.
Assessment: post immunization, shortly after developed hives on face, small bumps on trunk. Encounter attached. No respiratory symptoms. Tx: 10 ml of Prednisolone 15/5mg adminsitered, 10 ml of BENADRYL 12.5/5ml administered.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 30-year-old female subject who was vaccinated with Boostrix (GlaxoSmithKline). Concurrent medications included Prenatal vitamins and Norethisterone (Nor-QD). On 14 February 2011 at 15:15 the subject received 1st dose of Boostrix (1 ml, unknown, left arm). On 14 February 2011, less than one day or on 15 February 2011 the following morning after vaccination with Boostrix, the subject experienced swelling injection site and arm pain at injection site. The swelling injection site and arm pain at injection site has continued for about nine days. The subject was treated with Advil and warm compress. At the time of reporting the swelling injections site and arm pain at injections site were unresolved. The healthcare professional considered the events were possibly related to vaccination with Boostrix. Follow-up information was received on 16 March 2011. It was reported that the events occurred the day of Boostrix administration, 14 February 2011. The outcome of the events was unknown and the causality was possible. No additional information was provided.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # L001311 with expiration date 06-JUL-2016 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Raised scar (possible keloid). Approximately 1/4 inch in diameter.; Possible keloid; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the right arm on 18Mar2021 at 07:45 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, hypertension and hypercholesterolemia and sulfonamide allergy. The patient previously took aspirin and lycopene and experienced drug allergy. The patient received medications within two weeks of vaccination which are unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021 the patient experienced raised scar (possible keloid), approximately 1/4 inch in diameter. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events raised scar (possible keloid) were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache, before 7am Nausea 10am Bodyache 2pm Sore throat noon Fever 100.4
lost smell; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost smell) in a 50-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced ANOSMIA (lost smell). At the time of the report, ANOSMIA (lost smell) outcome was unknown. Not Provided      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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-Significant follow up appended to AER
day 0: deltoid soreness  day 1: tactile fever and general malaise  day 2: pressure like chest pain, non radiating,  2/10 in AM and 8-9/10 PM. fevers resolved. acetaminophen did not improved symptoms  day 3: chest pain continued   day 4: chest pain continued (ER visit)
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug/allergies reactions were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (route, lot # and expiration date were not reported). On an unknown date, the patient developed an unspecified injection site reaction. The outcome of injection site reaction was not reported. The causality assessment between the event and the suspect therapy was not reported. No product quality complaint (PQC) was involved. This is one of several reports, received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 27 year old female with no known drug allergies and no pertinent medical history reported, who on an unknown date was vaccinated with the first dose of GARDASIL.  On approximately 18-JAN-2008, she was vaccinated with a second dose of GARDASIL.  On approximately 17-JUN-2008, the patient was vaccinated with a third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified).  About three weeks after the first dose, the patient had a syncopal episode.  On 08-FEB-2008, about 3 weeks after the second dose, the patient experienced tonic-clonic seizure and was hospitalized overnight.  The patient was hospitalized from 08-FEB-2008 to 09-FEB-2008.  On 08-JUL-2008, about three weeks after the third dose, the patient experienced a second tonic-clonic seizure.  An electroencephalography, a magnetic resonance imaging and blood work were done and showed normal results.  She was started on an anticonvulsant medication.  At the time of reporting, the patient had not recovered.  Upon internal review severe tonic-clonic seizure was determined to be an other important medical event.  Additional information has been requested.  6/9/09 Hospital ER records received DOS 7/6/08. FINAL DIAGNOSIS: Seizure. Post vaccination pt's father witnessed seizure consisting of nonresponsiveness, drooling/twitching of mouth, loss of consciousness.   6/10/09 Neurology consultant records received DOS 8/12/08 to 4/20/09. Assessment: Partial Epilepsy NEC Without Intractable Epilepsy Teacher told parent that pt's right arm twisted up in chair, became unconscious, stiffened up, developed clonic activity, bit tongue. Developed rash and discontinued tegretol. Several months later stiffened up, eyes opened, unconscious. Both times had slurred speech and confusion afterwards. Placed on Keppra, dc'd due to nausea. Now on Topamax. Insomnia.
chills; Sore throat; some aching, like body aches; joint tenderness; some swelling at the injection site; arm tenderness; This is a spontaneous report from a contactable consumer reported for self. This 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 13:30 on Arm Left at single dose (lot: EK9231, Expiry: 30Apr2021) for covid-19 immunisation. Give her a follow up appointment for a second dose, that will be 02 Feb at 1:20 PM. Medical History included arthritis and had surgery for right knee replacement 6 years ago (2015). They are trying to figure out, she has water in her ear she has had CT scans recently trying to check for any problems that could be corrected surgically and that was all clean. She has had a mammogram, she was not sure about the mammogram yet but she thinks they would have called her if there was a problem with that. Historical vaccine included Just mild stuff with the flu vaccine for immunisation on occasion she has had similar reactions that were very mild with the flu vaccine and last year she had none of that at all. She says when she has had any other vaccine, she had no reaction other than maybe a slightly sore arm. No other products. She did have some mild side effects. She was really glad she got this shot. She said she had experienced some chilling on 13Jan2021, these are all very mild symptoms. She had a sore throat on 13Jan2021, some aching, like body aches on 13Jan2021 and joint tenderness on 13Jan2021. She just got chilled every once in a while. It was not very bad. She said the sore throat had persisted about the same, but the coffee helped. She was having some swelling at the injection site that was about the same as when it began on 13Jan2021. She was having some arm tenderness on 13Jan2021. She did not have any adverse reactions yesterday (12Jan2021) she was so excited to get it. Outcome of the events was not recovered.
She had Covid-19 after the 1st dose; This is a spontaneous report from a contactable consumer or other non-healthcare professional via RA. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Patient's medical history and concomitant medications were unknown. Patient underwent lab test and procedure which tested positive for COVID-19 on unspecified date. On an specified date, patient reported that she had Covid-19 after the 1st dose. She wanted to cancel her 2nd dose scheduled on 28APR2021 and asked if it can be rescheduled. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
chest is swelling; left arm too ( swelling); under his arm ( swelling); This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)). At the time of the report, CHEST DISCOMFORT (chest is swelling), PERIPHERAL SWELLING (left arm too ( swelling)) and PERIPHERAL SWELLING (under his arm ( swelling)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant  information was  provided. Treatment drugs include anti-inflammatory medication.
Sore at injection site for two day. On 10/25/08 had increased (L) arm pain, numbness of (L) arm and hand heaviness of (L) arm. Unable to raise arm (L) over head.
No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T000698, expiration date: 07-JAN-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005205: US-009507513-2106USA005206: US-009507513-2106USA005134:
Injection site bruising; Vaccination site pain; Fatigue; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), MALAISE (Feeling unwell), VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain) in a 32-year-old female 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.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 28-Feb-2021 to an unknown date for COVID-19 vaccination.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FATIGUE (Fatigue) and MALAISE (Feeling unwell). On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, FATIGUE (Fatigue) and MALAISE (Feeling unwell) outcome was unknown and VACCINATION SITE BRUISING (Injection site bruising) and VACCINATION SITE PAIN (Vaccination site pain) had not resolved. Not Provided          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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No  treatment medication provided
Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  pain in right arm (not injection arm).   Assessment : Time of assessment 10:37 B/P 152/93, temp 98.8, pulse 67, res 18.   Actions taken:  EMS called at  10:45. soon after call was cancled due to pt not wanting to wait to be evaluated. Pt stated she would call her MD and go to the ED if she needed to.   There were no vitals filed for this visit.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
About 5/16/01, developed low-grade fever. On 5/17/01 had dyspnea with mild exertion which persisted > 1 week. Diagnosed with hypomagnesemia and arrhythmias
fever; This is a spontaneous report from a contactable consumer or other non health care professional. This consumer reported for a male patient.  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, reporter husband and herself received the 2nd dose of the Pfizer covid vaccine yesterday. Today (on 19Feb2021) they both developed a fever, one ranged from 99-100 F and the other ranged 100.4-100.5 F. As per the documentation received form the facility they received the vaccine, they were advised to call their doctor if they had a fever, loss of taste, etc as they may need to take a covid test. But as for other symptoms, they make take pain medication. The patient underwent lab tests and procedures which included fever: 100.4-100.5 fahrenheit (100.4-100.5 F) on 19Feb2021. The reporter assessed the seriousness as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021184160 similar report from same reporter
Onset of symptoms started on 2/8/21, right sided weakness, difficulty walking fatigue nerve pain in Left leg (could not tolerate wearing pants). Started me on a Medrol dose pack 2/15/21, improvement of symptoms of pain in leg and fatigue, but continued to walk with a cane (prior to this did not walk with cane and exercised with weights 3-5 x week). On 2/27/21 onset of nerve pain in Left radial nerve and on 2/28 Trigeminal neuralgia right side of face. Stated another dose pack on 3/1, had relief of symptoms except for fatigue and walking  until 3/6. Still walking with a cane, Left arm pain and weakness, trigeminal pain fluctuates.
Varicella 1-22-08 in am, by evening, pt c/o pain. 1-23-08 - 4.5x5cm area around injection site, warmth and induration - itchy. Tx with Benadryl x 1-2 days.
Adverse event miscarriage.    First pregnancy. Estimated due date middle of November.   Received vaccine approximately around 7 weeks of pregnancy. Post vaccination had chills and fatigue starting 12 hours after vaccine lasting about 48 hours.
12 hours after receiving vaccine I woke with severe stabbing pain in stomach, moving up left side  went to ER about 48 hours later, diagnosed Shingles, slight rash on left side above breast around to left back shoulder  I continue to have shingles
I had gone on vacation and when I got back on Tuesday, I developed a cough. Thursday morning I had a sore throat so I took a home test and it was positive. I spoke to my neurologist who told me to contact my PC to get a prescription for Paxlovid. I began taking the medication on Friday. The illness got worse the 1st few days. Saturday it peaked but started getting better on Sunday. I still have a little bit of the cough and some severe fatigue remaining.
Information has been received from a physician concerning a 25 year old female patient with asthma, no pertinent medical history and no known drug allergies/drug reactions who on 13-MAY-2010 was vaccinated with her first and only 0.5 mL dose of GARDASIL (Lot # 661954/0075Y) intramuscularly (expiration date: 15-MAR-2011). Concomitant therapy included IMPLANON. It was reported that on 13-MAY-2010, the patient developed induration and swollen lump at the injection site after receiving GARDASIL. There were no laboratory diagnostic tests performed. The patient sought unspecified medical attention. At the time of the report the patient was recovering. Additional information has been requested.
I have been traveling and I was having congestion and a cough along with a headache. I took a COVID-19 Home Test, and it was positive; I ended up taking three of them which all showed that I was positive. I called an urgent care and because I had three tests, they did not test me again. They said I should use Flonase and cough suppressant as well to help with the symptoms and to continue with the Tylenol and Sudafed that I had been taking. The cough has progressed, but it has not settled into my lungs which is a good thing. I am almost better but fully recovered at this point.
I noticed a swollen lymph node under my right side jaw and I saw the doctor. I can't tell that it is changed any yet.
Patient called PCP complaining of headache and a reaction at injection site. Went to MD, small red circle at injection site - pt recovering.
petechial rash on ankles, lower legs, knees, thighs just above the knees, backs of hands, and forearms  Witchhazel, Cortisone 10 cream, Nyquil to stop itching and help sleep   Rash subsiding after 8 days and much less itchy but not gone yet
Received flu shot 12/31/13. 1/1/14 injection site okay but large bright red area below site. By 1/2/14, area red, bruised and reaching downward toward elbow.
Information has been received from an employee health registered nurse concerning a 56 year old female patient with no illness at the time of vaccination who on 07APR2003 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). On 21Apr2003 the patient developed a rash (trunk and face), swelling (wrists and knees) and pain. Follow up information noted that on 21APR2003 the patient developed a "rash , 4 days" and "painful joints 10 days." The patient required a doctor visit and the treatment was ibuprofen (Motrin). Follow up information reported that the patient had recovered. No further information is available.