chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via sales rep and described the occurrence of injection site erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, sleepiness and upset stomach. On an unknown date, the outcome of the injection site erythema and upset stomach were unknown and the outcome of the sleepiness was recovered/resolved. The reporter considered the injection site erythema, sleepiness and upset stomach to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced sleepiness, redness at the injection site, and upset stomach after receiving the SHINGRIX vaccine. He had to miss a day of work.
feeling really bad, Feel icky; fever; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm). At the time of the report, FEELING ABNORMAL (feeling really bad, Feel icky), PYREXIA (fever) and MYALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Had vaccine and on Sunday afternoon she laid down and took a 3 hour nap.  Patient does not generally bruise, noticed a 5" long, 2" wide, 3" from her elbow bruise underneath her armpit, blue in color.  Noticed it while drying her hair without a robe on.  Today, where the shot was given there is a temperature and a bruise surfacing there as well.  Went into the health site where she lives and got the fact sheet and our phone #, so decided to report it.  It was frightening to her as it was so large.  It is still there today, 1/25/21.  The one on top at needle insertion is at skin surface approximately 2-2 1/2" long.  Never felt her insert the needle for the vaccine, so is shocked that she is having reaction.  No treatment for it.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA GUILLAIN BARRE SYNDROME POLYNEUROPATHY
Very sore arm to start. Leg weakness. The next day very fatigued and still fatigued the third day too. General overall feeling of unwell. I have not sought medical treatment however as I don?t feel threatened by the symptoms yet.
After April 7th shot, the arm was so for a few weeks.   Received the second shot on May 5th.  The pain lasted a long time - 3 or 4 weeks.  Reports starting to lose her appetite and she was losing weight during the middle of June.  This continued on.  The weekend of July 4th, she reports knowing something was wrong.  On July 8th, she reports not being able to sleep and her right arm started to bother her a great deal.  On July 9th, July 10th and July 11th, the pain in the right arm was unbearable according to individual.  There is also swelling in the arm.   On July 12th, she went to the Walk-in center.   Doctor felt lymph nodes under the right arm that were swollen.   Individual had an ultrasound which showed swollen lymph nodes and fluid in that area.   She was given a prescription for Keflex and Naprosyn.
dizziness/light Headedness; nausea; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Jun2021 (Tuesday) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced dizziness and light Headedness and nausea on an unspecified date. The patient wondering if this was side effects and if this was suppose to go on this long. The outcome of the events was unknown.   Information about Lot/Batch number has been requested.
Fatigue, chills, hot flashes, muscle aches body and joint aches, debilitating headaches. Now two days later, I have Covid arm/red giant rash that itches near the injection site.
Patient complained of pain in L shoulder on 7/11/17. Shoulder/deltoid was red, hot to touch and swollen. Father marked area with marker. Notified doctor of event. Doctor recommend BENADRYL, IBU and ice. Followed Dr. orders. On 7/12/17, patient's arm was still hot to touch and redness and swelling increased in size. Dr. ordered son Cephalexin 500mg 1 capsule PO four times a day. Redness and swelling has started to decrease 7/13/17.
Patient reports left arm is still sore, with no improvement when he lifts up his arm.  Arm is tender to touch and mildly swollen.  There is no redness.  Pt has a fever, however he also has an upper respiratory tract infection with sore throat. "I've have been fighting a cold." Per pt. Pt was sent home with oral antibiotics and follow up instructions. As well as self care measures.
I have been nausea with no appetite, have had diarrhea, and abdominal pain and am still very fatigued in week 2 .In week 1 I had a fever right away and then with the above symptoms in week 2 I am struggling to keep liquids down.
Received Flu shot 12/06/2006 at clinic (Employee Health Flu clinic). On 12/11/06 developed red spots with whites heaves on both side of face and left dermatones, per her report, left shoulder. On 12/14/06 saw doctor dermatology department started her on Valtrex 3 times a day. Home from work until resolved. Resumed work 12/18/06 reported this to EHS on 12/27/06.
itchy and swollen around lips; itchy and swollen around lips; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips). At the time of the report, PRURITUS (itchy and swollen around lips) and LIP SWELLING (itchy and swollen around lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported  No treatment information was provided.   Reporter did not allow further contact
Been in pain ever since receiving booster dose vaccine; The patient can hardly use her arm; the booster dose Pfizer Vaccine but the pain has gotten worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: FH8020) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation; methoxy polyethylene glycol-epoetin beta (MIRCERA), administered in arm right, administration date 18Oct2021 (Lot number: X405R, Expiration Date: Mar2024) as unk unk, single. Relevant medical history included: "Dialysis", start date: 2019 (ongoing), notes: Verbatim: Dialysis (Patient began dialysis two years ago, peridenal). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 2nd, Lot: PF1725, Route of administration: Right arm), administration date: 06Feb2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1st, Lot: EL1284, Route of administration: Right arm), administration date: 16Jan2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Been in pain ever since receiving booster dose vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "The patient can hardly use her arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "the booster dose Pfizer Vaccine but the pain has gotten worse.". Therapeutic measures were taken as a result of pain.  Additional information: After receiving booster dose patient had localized pain and it got worsen and she was taking Tylenol (lot: SDA002) and that helped her shorter period of time and also put salonpas patch (lot: X5087, expiration: APR-2024) on and a heating pad, patient received micera vaccine on right side as same day of booster dose to do with blood for anemia. The patient doesn't visit emergency room.  No follow-up attempts are possible. No further information is expected.
pt states that she developed a bad headache next day after getting the vax.  Pt was very confused, vomiting,  and had brain fog so she called her son.  She was getting worse and having spots, stars and flashes in front her eyes so he took her the OSF ER on 2/5/2021.They did a CT and blood work.  Pt was admitted and assessed by a Neurologist and Physical Therapist.  She was told she had altered mental status.   She was stayed for 3 days and discharged.  She stayed with her son for 6 days and then went to her PCP which told her not to return to work at this time.  Pt will FU on 3/24/2021.
Fever (101.3), overall joint and muscle pain, headache, feeling unwell, pain/swelling/redness at injection site.  All resolved by approx. 3:00 p.m. 9/18/2023.
I did not experience any side effects / symptoms PRIOR to CV-19 vaccine.  I experienced numerous side effects (currently 789 pgs.) listed on:   April 11 first and only dose (BNT162b2) Lot No.: 1B002A.  Ref: TC21411-669998-3  My symptoms commencing 2 days POST vaccine: Fatigue, nauseated, weak, loss of appetite 2 days POST, 2 weeks. Blood pressure / pulse HIGH-LOW-HIGH-LOW etc...2 days POST, 1 week. Vestibular balance issues (like after 2 glasses of wine) EVERYDAY until mid Aug. then off & on until mid Oct. VERY SLOW HEAD AND OR EYE MOVEMENTS, otherwise increased sense of being off-balance. For 3 months, I eliminated morning coffee due to it's magnifying effect on my vestibular issues. Distorted motor skill movements i.e. arms / legs time lag coinciding with my vestibular issues.  Tremors which subsided after I ate & legs feeling heavy 3 months Aug. 01 hospital admission ITP. platelet count: 1,000, 4 units platelets 50 units IVIG Aug. 06 count: 105,000, current count: 196,000 NO medication.  Around 6 weeks prior I noticed micro signs. Just thought it was a sign of aging. Thank you.  Kind Regards, Patient
Biange Brain Tumor 11-3-22 to remove tumor, emergency surgery for infection of tumor. Craniectomy performed  12/11/2022. 6 weeks of iv antibiotics Nafcilin. 03-02-2023 performed Cranioplasty, prescribed oxycodone.
Patient reported getting flu shots every year for her job and this time, the pharmacist gave her the shot very high up on her shoulder. Immediately after, she felt pain and this pain has been lingering ever since the shot. She has to lift her injured hand with her non-injured hand to move it. She says the pain starts from her shoulder down to her elbow where she can't extend her arm and then down to her wrist as well.
injection was given 12/6/06 left deltoid IM. 12/13/06 pt started rash at injection site, circular size of quarter maybe larger.  Pt being seen 12/15/06 9am.  Dx. cellulitis, prescribed with Keflex
Increasing soreness in arm starting yesterday treated with ice, ibuprofen, OTC antihistamine today reports welts and can hardly move arm. MD appointment.
Red, hot, swollen around site V2V was given noticed daughter shot. Treated 2 days after shot. Tx with KEFLEX po x 10 days.
Superficial thrombophlebitis in left medial lower calf, along with edema in foot and ankle on same leg and pain in calf, foot, and ankle. No explicit treatment prescribed. Symptoms are ongoing as of 6/25/2021, but have reduced in intensity. The was the first blood clot I've ever experienced.
heart attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. The reported cause of death was myocardial infarction. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101881803 Same reporter/ drug/ event, different patient;US-PFIZER INC-202101881804 Same reporter/ drug/ event, different patient; Reported Cause(s) of Death: Heart attack
This spontaneous report as received from a consumer refers to a 83 year old female patient. The patient's medical history included hypertension. On 2002 the patient was vaccinated with ZOSTAVAX for prophylaxis. Concomitant therapies included lavender oil (LAVENDER OIL) and witch hazel(WITCH HAZEL). On 2017 the patient experienced insomnia. On 24-JUL-2017 the patient experienced herpes zoster. The outcome of herpes zoster was reported as not recovered/not resolved. The outcome of insomnia is unknown.
Per parents, she received her routine 4-month immunizations (DTaP-IPV-HBV, PCV, Rotavirus, Hib) on 1/30/18 and she seemed sleepier than usual that night. On 02/01, she started having episodes where her whole body would tense up, her mouth would turn downwards into a frown, her eyes would widen, and she would then seem to startle and let out a cry afterwards. These episodes typically only last for 1-5 seconds. She has no extremity jerking and has no post-ictal period afterwards where she appears very tired. They occurred multiple times on 02/01.
Moderna COVID?19 Vaccine EUA. My left eye has been red/pink since receiving my first dose.  After my second dosage my left eye was swollen shut for a few days. My vision in my left eye has been blurry since receiving my second vaccine.
Death   4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia  2) Chronic obstructive pulmonary disease, unspecified  Other: none
Sleepy; Tired; Shoulder pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 24Mar2021 at 10:00 (at the age of 33-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021, the patient experienced sleepy, tired and shoulder pain. The patient did not receive any treatment for events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the events sleepy, tiredness and shoulder pain was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
daily fever of 100+ since 2nd dose vaccination on 2/18/21. Fatigue, muscle aches and fever that start at 99 F in morning and rise to 100.5 F in afternoon. From 2/19/21 to 2/24/21 had daily fevers of 101 F.
This is a spontaneous report from a contactable nurse. A 59-year-old female patient of an unspecified ethnicity received PREVNAR 13 (lot S89564, expiry date Sep2018) via an unspecified route of administration in the left deltoid on 25Sep2017 at 12:19 pm at 0.5 ml single for routine immunization.  The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and pain at left upper arm since 26Sep2017 and she was diagnosed with cellulitis at left upper arm (vaccination site). The patient had previously received diphtheria, tetanus and acellular pertussis (TDAP) for routine immunization a few years before this report and she had experienced redness and swelling in the same arm. Reaction after pneumococcal 13-val conj vac (dipht crm197 protein) was more severe. The reporter was wondering if there was a relationship between the two shots (if it was an ingredient in the 2 vaccines or if it was just a lot number problem). Past vaccines given for immunization also included influenza vaccine in 2016 at work and hepatitis B vaccine series on unspecified dates. The reporter stated that the patient's symptoms had a gradual onset. The patient's left upper arm started to become red and swollen. The redness spread with pain. The area was outlined. The patient presented on 28Sep2017 with pain, swelling and redness for 3 days. Cellulitis was diagnosed and ibuprofen and warm compresses were recommended. The patient went to the see the on call doctor on 03Oct2017 and she was sent to the emergency room (ER). The patient was admitted to hospital on 03Oct2017 and treated with two doses of vancomycin and ROCEPHIN. The patient was sent home on FLAGYL after an unspecified number of days on an unspecified date in Oct2017. The symptoms were initially worsened, but the reporter was not able to talk to the patient since the ER visit, so the final outcome of event was unknown. The event was considered serious as medically significant event and per initial hospitalization. The reporter stated that the doctor and the patient felt that redness, swelling, pain, and cellulitis were related to pneumococcal 13-val conj vac (dipht crm197 protein), while the reporter did not have a personal opinion on it. Sender's Comments: Based on the information currently provided, the vaccination with PREVNAR 13 may play a contributory role in triggering the occurrence of cellulitis at left upper arm (vaccination site) considering the close time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After pain at site of injection subsided, a pain developed all the way down my right arm, through the elbow and through the ends of my fingertips; I also experienced weakness in that arm, i.e. difficulty lifting even very light objects.
Child received DTaP 10/31/02 am. 11/1/02 am, child's mother noted swelling on child's right anterior thigh at injection site. Child's mother and child came to health dept. 11/1/02 RAT reddened and warm to touch with approx. diameter of 1 1/2" swelling. Explained to mother to give Children's Motrin or Tylenol every 4-6 hours as needed and to place ice on area. Child to call family physician if symptoms persist/worsen.
Patient reported palpitations above 130 on his watch. Went to ER where they confirmed and treated. Patient contacted his cardiologist the following day and was fitted with a heart monitor to wear for 10 days. Patient also reported swelling and soreness at injection site.
COVID-19 test positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 test positive) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy, Environmental allergy, Cochlear hydrops, Aneurysm and Dysautonomia. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA 12 HOUR), MONTELUKAST SODIUM (SINGULAIR), GUAIFENESIN (MUCINEX), COLECALCIFEROL (D3 VITAMIIN), OMEPRAZOLE, FLUTICASONE and ROSUVASTATIN CALCIUM (RESTAT) for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 test positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 12-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 test positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient birth date was given as Jul 1961. The patient taking any other medications/products within 2 weeks of starting. COVID-19 treatment. Patient previously received a COVID-19 Vaccine of unknown company. Reported Event: Respiratory symptoms resolved during Paxlovid treatment. But the brain fog and fatigue continued post-Paxlovid treatment. Respiratory symptoms returned on May 22nd. Device Date : 22 May 2022  Company comment: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced the unexpected non serious ADR of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 12-May to 17-May. Respiratory symptoms resolved during Paxlovid treatment. Brain fog and fatigue continued. Respiratory symptoms returned and Patient again tested positive for COVID 19 on 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 60-year-old female patient with no relevant medical history who experienced the unexpected non serious ADR of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) as treatment for COVID 19 from 12-May to 17-May. Respiratory symptoms resolved during Paxlovid treatment. Brain fog and fatigue continued. Respiratory symptoms returned and Patient again tested positive for COVID 19 on 22-May. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. In September 2014 the patients were vaccinated with an improperly stored (Merck) VARIVAX (dose, route, lot number and expiration date not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.