chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported.; a patient received an expired dose of VARlVAX; Information was received from a medical assistant referring to a 33 years old male patient. The patient's medical history, concurrent condition and concomitant medications were unknown.  On 24-OCT-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023961, expiration date 01-SEP-2019; dose and strength were unknown) subcutaneously for prophylaxis along with sterile diluent (STERILE DILUENT) (lot # N026288, expiration date 8-FEB-2020, dose and strength were unknown). The varicella virus vaccine live (oka/merck) (VARIVAX) was stored properly. No adverse effects were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA015506:
Patient developed hives on April 20th. Possible related to tetanus vaccine. Also was taking amoxicillin and ibuprofen. No prior hx of adverse reaction to either med or tetanus vaccine.
This spontaneous report as received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-APR-2014, the patient was vaccinated with a dose of improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 1632 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Individual stated that during the time of vaccination, the vaccinator had difficulty getting the medication injected through the needle to the skin. Individual stated that the vaccine was cold which could have caused the pain and discomfort. Individual has not been able to really use her arm, has a lot of pain, throbbing, and discomfort, the pain is worse at night time and keeps her up because of it. Individual stated that it hurts worse at night. Individual did have physical therapist check it out but nothing was resolved. Flu Shot Coordinator suggested seeing PCP.
That night I was freezing. The morning of the 28th every muscle and joint felt sore and almost knotted feeling. I felt very weak and slept most of the day. The morning of the 29th I am still sore and weak but do not have the knotted feelings.
She states she felt icky; she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms; she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 2, single (Lot number: EN6203) at the age of 86 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SULFASALAZINE; FUROSEMIDE; FOLIC ACID; ATORVASTATIN; METOPROLOL taken for blood pressure measurement; PREDNISONE taken for arthritis; RABEPRAZOLE taken for abdominal discomfort. Vaccination history included: BNT162b2 (Dose number:01, Manufacturer: Pfizer, Batch number: EM9810), administration date: 09Feb2021, when the patient was 86-year-old, for Covid-19 immunization. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "She states she felt icky"; PAIN (non-serious), INFLUENZA (non-serious), outcome "unknown" and all described as "she felt like the flu so achy and icky and that was all. She states she can tolerate those symptoms".  Additional information: she has been on Sulfasalazin for a long time. Caller states she doesn't know why she is taking Sulfasalazin but has something to do with the liver or the kidneys. Caller states she was on 4 of those pills but is now only on 2. She clarified the medication was for her kidneys. Metoprolol: Caller stated she used to take 2 but was cut back to 1 tablet because her blood pressure was to high and the medication was to get her blood pressure back down. She stated she had been on Metoprolol for a long time like 10-15 years. Her blood pressure was 140 or 144 but is down to 110 now. She stated the nerve in her neck that has degenerated with old age is causing her balance to be off and she could not drive a car. She stated she fought with this all winter.
1 wk after injection, pain at site which extended to acromion and worsening over 1 wk. MRI shows labral tear and minor tendon tear of deltoid.
Achy; High Fever 102 Fahrenheit; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PYREXIA (High Fever 102 Fahrenheit) and CHILLS (Chills) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN (Achy), PYREXIA (High Fever 102 Fahrenheit) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), PYREXIA (High Fever 102 Fahrenheit) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: high (High) High fever 102 Fahrenheit reported.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient just mention she is taking blood pressure medication as concomed   This case was linked to MOD-2021-021377, MOD-2021-021328, MOD-2021-021270 (Patient Link).
Chest pain; Joint pain; Headache; Low grade fever; Body aches; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; dose number=1: 18Jan2021 07:00 PM; dose number=2 26Dec2020 04:00 PM; This is a spontaneous report from a contactable nurse (patient). A 34-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 18Jan2021 19:00 at single dose for covid-19 immunization. Medical history included allergies to penicillin (reported as PCN), azithromycin (reported as Z-Pack), hydrocodone bitartrate, paracetamol (NORCO). The patient's concomitant medications was reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the first of BNT162B2 on 26Dec2020 04:00 PM at right arm for covid-19 immunization.  The patient experienced chest pain, joint pain, headache, low grade fever, body aches on 19Jan2021 10:00 with outcome of not recovered. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the lot/batch number has been requested.
Swollen lymph node in left neck on the same side as my Moderna COVID-19 Dose 1 vaccine (upper left arm)
3 days post 2nd shot pt had extreme calf soreness and joint pains in shoulder and knees with some swelling.  He had never experienced these pains before in his life. He said it limited work ability even though his job is not very strenuous at a paper mill. H said he ended up going to dr office where he got 7 days of prednisone which made pain go away but when he stopped pain came back.  He was back today again for more pain meds.
7 day post-shot still experiencing pain in arm focused at site of injection.  Waves of extreme fatigue requiring me to sit down and overwhelming desire to sleep (unusually) three times day.  First dose.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. No information about medical history, concurrent conditions was reported. The patient had an unknown reaction to sulfonamides. On 26-AUG-2014 the patient was vaccinated with ZOSTAVAX (lot# K007548, dose not reported), single dose subcutaneous in the left arm. No concomitant medications were reported. On 27-AUG-2014, 1 day after onset of therapy the patient developed redness, tenderness, and induration at the injection site. The patient self-treated with ibuprofen. The patient came to the pharmacy on 28-AUG-2014, because the reaction is getting worse. The patient has been referred to her provider for evaluation. No lab diagnostics studies were performed. The patient sought medical attention at the pharmacy. There was no product quality complaint. The outcome was reported as not recovered/not resolved. The causality of the event was not specified. Additional information is not expected.
I was sick for 3 and a half months. My blood pressure would not regulate. My heart rate kept going over 130  and l ended up in the ER about 13 times in the space of 3 months.  Finally My pop sent me to a specialist and he said l had inflammation and it had to wear off. It wS the worst experience of my life. Now l donot know what to do about the booster shot because the doctors cannot tell me what they will do if it happens again. I have filled this firm out two times already and you all won't tell me what to do either. What do l do? I need to know if you all know what to do if l get the same reactions as before.
Case number PHEH2014US012552 is an initial spontaneous report received from a medical assistant on 11 Jun 2014. This report refers to a 12 years old female child. She was vaccinated with MENVEO (batch number: A13047 and expiry date: May 2015) on 10 Jun 2014. This vaccine had reached 51 degree Fahrenheit for two hours. The dose was administered to the patient at 4pm and excursion of MENVEO was discovered at 4.45pm on the same day. No adverse event was reported following this administration error.
Fever of 101 body aces, chills, loss of energy, felt like a flu.
Complaint of warmth and swelling of right upper arm, chills and fever, increased fatigue. Treated for cellulitis on 8-23-17 with AUGMENTIN.
Right chest pain, he was transported to another hospital. Spent the night in hospital and released home on July 20 with a follow up with his pediatrician and a heart doctor.
p/vax pt exp swelling of site; also had inc crying; seen on 9/7 & tylenol; ice +/or heat was prescribed
Painful belly cramps and severe diarrhea.  Took imodium.  It is now around 12:30 p.m.  I still have some cramps and still have loose stools, though not as bad or as frequent as early this morning.
First vac 3/8/2021 lot#027A21A mild symptoms for 24 hrs. Second vax, 4/5/2021 after 13 hours had horrific symptoms was crippled in pain in bed. Couldn?t open my hands for days joints in horrific pain, massive headache, felt like i was dying. Worse than any fluI ever had. High fever , took lots of Advil and pain meds, sinus congestion cough etc almost had my husband take me to hospital. Lasted for 3-5 days before I could get out of bed, And took another few days until I gained my strength back.  My booster shot on  9/18/21 after 12-15 hours me and my husband both experienced mild flu symptoms for 3 days that were tolerable. And took us about another 3-5 days to get our strength back. And after 3 series of vax I got covid 3 mos after my third shot. The body?s aches were unbearable after 2-3 days and my entire throat and sinuses swelled up and couldn?t eat or swallow. 4 months later and still having issues from getting covid. My entire household was exposed to me including my elderly parents and NONE of them experienced any symptoms or felt they ever got sick with Covid. vaccines don?t work, it makes no sense was I was miserable with 3 vaccines and then got covid. I am the only one who was every symptomatic and extremely ill. My husband is high risk diabetic and he only had issues with booster shot vaccine having side affects.  You need more information to treat covid as friends I know who never vaccinated had covid with mild symptoms and down for 24 hours. Months later and still having issue from covid and had 3 modern vax !!! Will no longer wear a mask nor ever get another vax for covid  again in fear of my reaction the 4th time, still have joint pain issues, swelling, and heat cramping from time to time. I?m bar,he 50 years old in great shape. This vaccine kicked the crap out of me twice and then The virus  was just as awe full.
Had sudden onset of menstrual bleeding. Even when I wasn't due for more than a week; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 24-year-old female patient (not pregnant) received COVID-19 VACCINE - MANUFACTURER UNKNOWN, administered in left arm, administration date 02Mar2022 at 18:00 (Lot number: unknown) at the age of 24 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "None". Concomitant medications included unspecified birth control medication. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 02Mar2022 at 23:00, outcome "not recovered", described as "Had sudden onset of menstrual bleeding. Even when I wasn't due for more than a week". Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: It was reported that the patient was fairly regular and never had breakthrough bleedings, so it wasn't something else that she had been doing like she normally does that's caused it. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 25 minutes after JE Vax given, patient reported tightness in chest followed by tightness in throat and difficulty swallowing, denied shortness of breath; VS and O2 Sat good about 10 minutes after onset of symptoms, patient given Benadryl 50 mg IM in left deltoid and observed symptoms did not resolve. Approximately 10 minutes after Benadryl, patient reported numbness/ tingling in left arm that did not resolve with position change, also reported fingers feeling cold though color good, warm to touch, and nailbeds blanched and recovered well. Ambulance summoned and transported to ER. 5-2-07 Patient reported spending 3 hours in ER but feeling "fine" on this day. Patient came to clinic to give info was given Dexamethasone and Pepcid in ER, slept for 3 hours and woke up feeling "good." Discharged from ER with Rx Benadryl and Rx Prednisone 4 days. Has completed meds and resumed normal activities. No more JE Vax to be given. Additional note - patient is allergic to latex; syringes and needles used were latex free.
On 08/23/2000, approximately 12 days after her son developed a rash, the patient developed a rash described as "5-6 lesions below her ribs, 3 lesions on her back and a number of lesions on both arms, behind her ear, and at the base of her hairline. There was a total of 25-30 lesions." The lesions were itchy and resembled mosquito bites. Subsequently, the patient recovered. The reporter stated a concern about the lot (632043/1360J). Five additional patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of injection site pruritus in a 82-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 at 12:01 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 1 October 2008, immediately after vaccination with FLULAVAL, the subject experienced injection site pruritus. Over the next two weeks, the itching spread to her arms and legs. She also developed an injection site rash and then a maculopapular rash spread to her arms and legs. The itching was in the same areas as the rash. The subject treated herself with BENADRYL. the events were ongoing, but improved at the time of reporting. The healthcare professional considered the events were probably related to vaccination with FLULAVAL. Follow-up information was received on 05 January 2009, via healthcare professional who reported the subject had received her shot on 01 October 2008. On 02 October 2008, she started itching. The rash started on 02 October 2008, but later in the day. The symptoms were very acute , one night the subject almost went to the emergency room. The subject was "trying to stick it out to see if it would run its course but it got too bad that I had to go to my doctor. I was red all over and itching like mad." The subject's primary care physician started the subject on ATARAX. Per subject rash and itching persisted. The subject was referred to an allergist. The subject reported to the healthcare professional on 19 December 2008, that she had been seeing a dermatologist who prescribed Triamcinolone Acetonide Ointment 0.1% twice daily, which has helped with pruritus; "itched for 57 days and two days later I stopped itching". "Rash is gradually disappearing, but I still have a little". The subject also stated that on 17 December the she had seen an allergist, "they did 96 patch test on me, they said I was allergic to glutaraldehyde (glutaral - test score 45), kathon (test score 17), neomycin (test score 3), and benzocaine (test score 5)." Plan is to eventually wean off Triamcinolone ointment from twice daily to once daily to no ointment at all. The subject is planning to follow-up with allergist and dermatologist in January.
Information has been received from a pharmacist concerning a pt with HIV disease who was vaccinated with a first and second dose of hep A virus vaccine inactivated. In Nov 2005, the pt had a recent titer which failed to show seroconversion. Unspecified medical attention was sought. There was no product quality complaint involved. It was reported that the pt failed to show seroconversion following hep B virus vaccine rHBsAg (yeast) (WAES0511USA03543). Additional information has been requested.
The patient called the pharmacy reporting that she developed Bells Palsy shortly after receiving her first COVID-19 Pfizer BioNTech vaccine. She did report that she had some dental procedure within the same time frame and was not sure if the vaccine or her dental work that caused her symptoms. She did tell me that her symptoms were on the same side as her dental work and that her symptoms resolved within 2 days, but her physician did tell her it was Bells Palsy. She called our pharmacy as she is supposed to receive her second COVID vaccine tomorrow and was not sure if she should still get it still with this reaction. I informed her that the vaccine was unlikely to be the cause of her Bells Palsy symptoms and that she is still indicated as an individual who should receive the second vaccine.
PE lower lobs of my lung; diagnosis of sever DVT left leg (ankle to groin); This is a spontaneous report from a contactable consumer reported for himself. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9262) dose 1 via an unspecified route of administration, administered in left arm on 28Jan2021 12:45 PM (74-year-old at vaccination) at a single dose for COVID-19 immunisation. Medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On Friday, 29Jan2021, the day after his 1st shot he began having pain in the lower left leg. Adverse event start date was on 29Jan2021 11:00 AM. The pain intensified through Sunday. On Thursday 02Feb2021 went to emergency room (ER) Confirmed diagnosis of sever deep vein thrombosis (DVT) left leg (ankle to groin) and pulmonary embolism (PE) lower lobs of his lung; on 04Feb2021. Now on apixaban (ELIQUIS) for 6 months. The adverse event result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse event included apixaban. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not resolved.  Information on batch/lot number has been requested.
injection site was red and swollen; injection site was swollen; injection site was red; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from Consumer/Non-HCP (Medical assistant).  This case involves a 6 years old patient who experienced the injection site swollen and redness (Vaccination site swelling), (Vaccination site erythema) and (Vaccination site inflammation), while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The medical history, medical treatments, vaccinations and family history were not provided.  On 10-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT6645LA Expiry date: 30-JUN-2020) via intramuscular route in the right arm.  On unknown date, the patient developed a non-serious injection site swollen and redness (vaccination site swelling), (vaccination site erythema) and (vaccination site inflammation) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 12-Nov-2019, patient visited to physician for the follow up of laceration of foot.  Other relevant tests included No lab data.  Final diagnosis was the injection site swollen and redness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown for all events.
Swelling, tenderness, redness. Tx. Zyrtec 10cc daily for itching, Motrin 2 tsp every 6-8 hrs with food.