chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep), ASTHENIA (weakness), DIZZINESS (lightheadedness), DIZZINESS (dizziness) and PAIN (body aches) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Environmental allergy (patient is under Flonase and Zyrtec). Concomitant products included Multivitamins                                                  for supplemental purposes, Fisoil                                                         for supplemental purposes, Zyrtec                                                         for environmental allergy and Biotin                                                         for supplemental purposes for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), FATIGUE (tiredness) and CHILLS (chills). On 14-Mar-2021, the patient experienced DIZZINESS (lightheadedness), DIZZINESS (dizziness) and NAUSEA (extreme nausea). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at a dose of 1 dosage form and IBUPROFEN for Pain relief, at a dose of 1 dosage form. On 15-Mar-2021, INSOMNIA (couldn't sleep), ASTHENIA (weakness), PAIN (body aches), PYREXIA (fever), NAUSEA (extreme nausea), FATIGUE (tiredness) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (lightheadedness) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received expired vaccine. Local health dept. and Pfizer recommend revaccination. Patient was contacted to schedule an appointment. He will schedule second dose when new shipment arrives. States he experienced arm pain for 1 week.
PATIENT EXPERIENCED VASOVAGAL RESPONSE TO VACCINATION IMMEDIATELY AFTER ADMINISTRATION. PATIENT FAINTED FOR SEVERAL SECONDS, THEN EXPERIENCED DIZZINESS, LOW BLOOD PRESSURE, AND PROFUSE SWEATING. ALL SYMPTOMS RESOLVED WITHIN APPROXIMATELY 10 MINUTES.
Information has been received from a physician concerning a patient who were vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced "localized reaction that required follow-up visits-not a varicella-like rash". The physician stated that he believed that the patient had to come back twice. There was no pharmacological intervention. The physician reported that he has started vaccinating his adolescent patients with a second dose of varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Menstration problem. Severe Increase in bleeding and blood clots  Breathing problems- inhaler prescribed
Patient is a 27 year old female who presents to ED with left arm redness and swelling at the injection site of her J&J COVAX from last Tuesday. No fever, no chills, no other symptoms.
Patient reported that awhile (possible weeks to a month) after the vaccine she began to notice that she was having issues of lost strength when lifting items with the right arm. When she went to lift items (teapot etc.) she would have to use her other arm to help lift and steady the arm. She believes that the symptoms lasted approximately 6 months and then resolved.  She did not go to the doctors office or have any other complications with her other vaccine/arm.
having some chest pain again; he had low grade fever; tiredness; headache; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number 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. The patient previously received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization with adverse event of sore arm and normal flu like symptoms. On an unknown date, Consumer stated, "I tried calling different places and they finally said why don't you check with Pfizer, this is actually in regard to my son, he got the second dose with Pfizer yesterday. He just called me, he had it yesterday, and he had low grade fever and the tiredness which was expected, so this morning he went in to work, it started with a headache and he said he was having some chest pain again, was that one of the normal side effects. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number.
This spontaneous report as received from a pharmacist on 21-NOV-2014 refers to a 61 year old male patient with hypercholesterolemia and hypertension. Patient had no known allergies. On 14-NOV-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX vial 19400 PFU (lot # K009770, expiration date: 09-OCT-2015), subcutaneous in the left upper arm. The primary reporter was requesting a lot check for the lot of ZOSTAVAX that the following patient received. Concomitant therapies included hydrochlorothiazide, PROZAC, LIPITOR and losartan potassium (Manufacturer unknown). The reporter stated that the patient developed "disseminated zoster", almost immediately after receiving ZOSTAVAX. The event onset date was also reported as 15-NOV-2014. She reported that the day after the patient received ZOSTAVAX (15-NOV-2014), the patient started itching, and then he developed varicella-like lesions on his body. The reporter stated that the patient was a physician, so she believed that his opinion was credible. The patient consulted physician for seeking medical attention. There was no lab diagnostics studies performed. The reporter stated that the patient did consult his healthcare provider, and a nurse practitioner in his physician's practice, prescribed VALTREX for him. The patient filled the prescription for VALTREX on 21-NOV-2014 (also reported as today) and he had started taking VALTREX. For an answer to the questions about significant disability, the pharmacist stated, she hadn't been seeing his patients because of this rash, so she might consider this adverse event significant disability since he couldn't work right now. The outcome of disseminated zoster was reported as recovering/resolving. Additional information has been requested.
Note:  *I did test positive Covid-19  in November 2020,  had full recovery and symptom free 90 days before before receiving vaccine.*       1st Dose @ 10:30 am on a Saturday.    45-60 minutes (11:30 am)after dose.  Light headed and dizziness.   By  4:00pm body & joint aches.  @ 7:00pm- Chills started with 99.8 fever.   @11pm fever @ 100.6 with bad cold chills.   Fever and Cold Chills progressed over next 30 hrs. peaking times @ 101.2.  On Monday approximately 4 am fever broke to 99.2, bounced up and down over next 6 hrs. before dropping below 99. By end of day on Monday. 48+ hrs. after 1st dose, No sides effects other than fatigue from experiencing side effects
That night( 2/12/09) he was shivering, temp taken, was 94 degrees. At 2 am,his temp was 103. He had an uneasy stomach for a few days. Nausea but no vomiting,no diarrhea. Next day temp was 100. 3rd day,temp was normal. No rash,no resp.distress. He stated after his first Rabies shot he had an uneasy stomach,achey joint and his legs hurt for 2 days.
local rxn in lt arm;swelling, tenderness & warmth;c/o bad itch over entire body;
High blood pressure of 197/97, and 226/106; pains in navel, aching; headache; dizziness; A spontaneous report was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, high blood pressure of 197/97, blood pressure was 226/106, pains in navel, headache, and aching.  The patient's medical history included allergies to sulfa, tetanus shots, and amoxicillin. Products known to have been used by the patient, within two weeks prior to the events, included losartan.  On 23 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced dizziness. On 11 Mar 2021, the patient experienced a blood pressure of 197/97, and took two blood pressure pills. The patient went to the emergency room and her blood pressure was 226/106. The patient was not given any treatment at the hospital. The patient also reported having pains in navel and a headache.  Action taken with mRNA-1273 in response to the events was not reported.   The outcomes of events, hypertension, dizziness, pain, headache, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient called the pharmacy on 01/18/2019 to report that she was having a reaction to the SHINGRIX vaccine. Patient explained that she was having pain, redness and swelling at the injection site. She also explained that she had a rash surrounding the injection site. I advised the patient to monitor all reactions and if they get worse to seek medical attention or follow up with her doctor. I recommended that she could take BENADRYL over the counter and/or use hydrocortisone 1% cream to help with the rash. I also recommended ibuprofen for the pain and swelling.
Patient said she was having a really bad headache and arm pain.  She said her pain meds and extra strength tylenol was not relieving any pain. She said she was also having some nausea
The same afternoon after the shots, in each arm, developed severe pain, significant swelling, severe restriction of movement of both arms, severe redness, nausea, feeling generally ill. I took 1/2 of a tylenol with codeine for pain and Medrol. I returned to Pharmacy Clinic to report my adverse reaction to the shots on 1-18-2018, met with NP who documented my record and adverse reaction to the shots. I continued feeling ill for weeks with pain, swelling, restricted arm movement (both arms), feverish, abdominal pains, general weakness and muscle weakness, as if I actually had the flu. I attributed all of these symptoms to the shots and subsequent reaction, since intramuscular route.
About 2 weeks after vaccine, spouse checking pulse ox and HR was 120's. Seen by cardiologist about a month later, EKG, ECHO ordered. ECHO done by July 2021 and Ejection fraction 47%, DX with idiopathic tachycardia. No reason for poor EF given  by cardiology- would not acknowledge NP spouse wondering about myocarditis from vaccine. Repeat Echo 1 year later July2022 EF up to 55%, repeat echo 7/23 Ejection fraction has normalized at 67%. Tachycardia lasted about 6 months on and off.
I have had a headache every day since I have taken the vaccine and some days are extremely severe.
Knot on R arm came up after flu shot and has progressively gotten bigger, sore and warm to touch, and red. Treated with antibiotic with f/u if no improvement.
This spontaneous report as received from a pharmacist refers to a male patient who had received PNEUMOVAX 23 every year beginning 2009 and last in 2012, at an unspecified healthcare provider. No adverse effect was reported. Additional information has been requested.
patient has been given expired PENTACEL with no adverse event; Initial information received on 14-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient of unknown gender and age who experienced patient has been given expired pentacel with no adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine expiry date: 29-May-2022, frequency: once (dose, route, strength, formulation, batch lot number: unknown) in unknown administration site as immunization.  On an unknown date the patient developed a non-serious event patient has been given expired pentacel with no adverse event (expired product administered) (latency: same day) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (expired product administered).  At time of reporting, the outcome was Unknown for the event expired product administered.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a healthcare worker refers to three infants. The patient were vaccinated with a first dose of RECOMBIVAX HB (lot #, dose and route not reported) at birth on unspecified dates. The patients also received doses 2 and 3 of either RECOMBIVAX HB (lot #, dose and route not reported) or COMVAX (lot #, dose and route not reported at 2 months of age and then at 4 months of age. No adverse effect was reported. Additional information has been requested.
About a week after vaccine (02/01/2021) I started lactating out of both nipples. I did go to the Doctor to get a pregnancy test and it was negative. They tested my prolactin levels and they were increased. I got them tested again and one came back normal but another one was high. I got an MRI to rule out anything else but it came back clear. I had high prolactin levels. The day after the vaccine I did have burning of my skin that lasted for 10 days. Anytime I put on unscented lotion it burned. The feeling would go away after 5 minutes but it was still intense.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).   In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756538A, A0756540A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Information has been received from a physician concerning a 19 year old female with penicillin allergy who on 19-FEB-2009 was vaccinated IM into the left arm with a first 0.5 ml dose of GARDASIL (661046/0546X). Concomitant therapy included hormonal contraceptives (unspecified). On 19-FEB-2009 the patient experienced pain and numbness in left arm and forearm. The patient sought medical attention at physician's office on 26-FEB-2009. No lab test were performed. The patient was told to take ADVIL and to call the office if her symptoms did not improve within a week. The physician has not heard from the patient. As of 2-MAR-2009, the patient's outcome was unknown. It was reported that the patient did not want to continue the series. Additional information has been requested.
I received H1N1 vaccine on 10/29/09. On 10/30/09 my R arm was very sore. All muscles in my body sore. Difficult and painful to raise arms over head. Pain continues as of 11/10/09. I have had no fever, headache or other symptoms. I have tried ADVIL and acupuncture. I continue to feel ill with very sore, achy joints and muscles.
BODYCHILLS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 54 year old. The patient's weight was 160 pounds, and height was 68 inches. The patient's concurrent conditions included non smoker, alcohol user, and treenut allergy, and other pre-existing medical conditions included the patient was not doing any drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, expiry: 05/MAY/2021) .5 ml, administered on 06-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced bodychills. On 06-MAR-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bodychills, and muscle aches. This report was non-serious.
Pt recvd 3 doses of Engerix-B & did not seroprotect; titers were drawn 1 yr p/3rd dose;
COVID-19 Vaccine, Pfizer BioNTech is administered after its useful life. Shelf Life Date 11/17/2021 7:00am.
Information has been received from a registered medical assistant referring to a 30 months old (reported as two and 1/2 years old) patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 11-MAY-2015, the patient was vaccinated with the first dose of VAQTA (lot #, expiration date and dose were not reported, intramuscular). On 10-FEB-2016, the patient was vaccinated with the second dose of VAQTA (lot #, expiration date and dose were not reported, intramuscular). On 10-AUG-2016 (also reported as "today"), the patient was inadvertently vaccinated with the third dose of VAQTA (lot # M002268 with expiration date 20-SEP-2017, dose unknown, intramuscular) (extra dose administered). No adverse effects were reported. Additional information has been requested.
Injection site reaction. Redness in area, warmth, pain initially but has worn off after 4 days.
pain at injection site, low grade fever 99.8, headache, chills, joint pan, fatigue/exhaustion all started about 24 hours after receiving vaccine, took Tylenol. felt better next day, still soreness at injection site but other symptoms improved.
4-3-07 mom reported by phone, localized redness of L deltoid area, warm to touch. 4-4-07 mom called stated redness and warmth from deltoid to elbow. Recommend child to be seen. Child was going out of town - mom refused appt.
A nurse reported that a female pt received an injection of tetanus toxoid absorbed and subsequently developed "swelling". This report was received on 2/29/00, no further information was available at that time.
Fever of 100; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient) reported that she received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: unknown; Expiration date was not reported) via an unspecified route of administration on 02Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization (age at vaccination:67-Years-old). The patient's medical history and concomitant medications were not reported. On 03Mar2021 the patient had fever of 100. It was reported that the patient had a fever of 100. was she supposed to take Tylenol. Reporter enquired that she wants to know if she can take Tylenol after receiving the COVID shot. The patient's laboratorial value included that the temperature was 100 after the receiving the bnt162b2. Temperature was 97-98 before the COVID Shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
paresthesia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "paresthesia".  Additional Information: The suspect product is reported as Covid-19 Vaccine and unspecified if the Covid-19 vaccine is a Pfizer product. He received the first dose on 26Feb2021. He experienced paresthesia in his right leg that moved to both legs and feet, arms and hands. Patient reported that other people have had the same thing. No details were provided. He was asking if it is likely to get worse or will it go away.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning her daughter who was vaccinated with a dose of MMR II at 12 months of age. Subsequently, the results of a titer drawn in Dec 2001 did not show immunity to mumps. Unspecified medical attention was sought. Additional info has been requested.
Around 4:30 pm on day if vaccination I started feeling nauseous and had the chills. Then around 8 pm my arm became extremely sore to the point where I could not lift it without 10/10 pain and when I touched it my pain was also 10/10. As the night progressed my body not only had the chills but I got a temperature of 102 and I was on fire. I could not cool down until my significant other put cold compresses on my forehead chest and arm. I felt all of those symptoms until about 5am when my fever finally broke. The next day I continued to have a headache and mild soreness in my arm. Then that night I had mild chills and night sweats and a mild temperature. I was therefore out of work for two days following the vaccine.
Pt received vaccine on 7/19/05. Pt returned to clinic on 7/21/05 for PPD check and MOC, showed RN, lt thigh of pt which had a large red, hot to the touch area covering 1/2 of pt's thigh. Pt seen by MD and placed on Abx's.
no swelling   dizziness, tachycardia  Cardiovascular: RRR  Respiratory: Normal effort, CTAB  Extremities: ROM normal  Skin: No rash   Neuro:  Oriented x 3    Interval Time:   1454   Repeat VS:  108/68 P 77 o2- 98%    Dispo:  Symptoms resolved. Stable-
pt recvd vax & devel erythema multiforme one month following vax;No further details were provided;
Contracted COVID 19 . Exposed on  9/20/22. Tested positive  on 9/25/22 when symptoms appeared.  Paxlovid prescribed.