chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain shooting down her left arm; Chest pain went away/reoccurred again; This spontaneous case was received on 21-Feb-2023 from other non-healthcare professional (consumer - patient's husband) (reference number: SEQW23-00689) and concerned a female patient of unreported age.   The patient's medical history and concomitant medications were not reported.  On 20-Feb-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular (IM), anatomical location: left arm, dose: 0.5 ml) as influenza prophylaxis. The batch number reported was 942396 and the expiry date was 30-Jun-2023.  On the same date, about two hours after receiving Flucelvax Quadrivalent, the patient experienced chest pain which went away.  On 21-Feb-2023, one day after receiving Flucelvax Quadrivalent, the chest pain reoccurred again and was also accompanied by pain shooting down the patient's left arm. The patient received no treatment for the events.  The reporter called to see if these adverse events were something that had been seen before with Flucelvax Quadrivalent and what the patient should do regarding it.  At the time of initial reporting, the patient had not recovered from the events.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Company comment: A female patient of unreported age experienced chest pain which went away, two hours after vaccination with Flucelvax Quadrivalent. Reportedly, one day after vaccination the pain reoccurred and was accompanied by pain in the extremity. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on temporal and anatomical plausibility.; Sender's Comments: A female patient of unreported age experienced chest pain which went away, two hours after vaccination with Flucelvax Quadrivalent. Reportedly, one day after vaccination the pain reoccurred and was accompanied by pain in the extremity. Information regarding the underlying medical history and concomitant medications has not been provided. Information regarding the related diagnostic findings was not provided. Causality is assessed as possibly related for both events based on temporal and anatomical plausibility.
tongue and throat swelling, painful tongue (that hurt in the same way as when I'm exposed to sunflower oil or seeds), hives from 16 or 17 minutes post shot to ten days after shot controlled with Benadryl a few times per day, doctor added in Allegra 1x per day in AM and small dose of Benadryl mid day and larger dose of Benadryl in evening. Adding Allegra with the Benadryl helped. I had an epi-pen available if needed. I chose not to get a steroid shot to stop reaction because i wanted to keep making antibodies so I can still have the benefit of being fully vaccinated. Other symptoms that may have been normal vaccine symptoms or part of the allergic reaction: nausea, diarrhea, chills, fever
Forty-eight hours post vax, this pt developed a red swollen area at injection site.
nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients). At the time of the report, ACCIDENTAL OVERDOSE (nurse applied 1ml instead of 0,5ml , to a maximum of 12 patients) outcome was unknown.    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.   concomitant medicines was not reported by reporter   treatment information was not provided
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional by phone. This case is linked to case 2018SA328295 (same reporter). This case involves a 28 years old female patient who experienced dizziness, felt nausea, vomiting and exposure during pregnancy, while she received vaccine ADACEL. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported dizziness, felt nausea, vomiting and exposure during pregnancy occurred at unknown gestation period and the patient was exposed to DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE at -8 weeks of pregnancy, during third pregnancy trimester for DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The date of last menstrual period was reported as 24-Apr-2018. The estimated due date is 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies. On 13-Feb-2017, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via intramuscular route in the left deltoid. On 26-Nov-2018 she also received a dose  of the same vaccine (lot number: U5979AA) via intramuscular route in the left deltoid. On an unspecified date, the patient developed a non-serious dizziness following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unspecified date, the patient developed a non-serious felt nausea following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unspecified date, the patient developed a non-serious vomiting following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was a case of exposure during pregnancy. Relevant prenatal testing after exposure not reported. Other relevant tests included No Lab data was reported. Final diagnosis was exposure during pregnancy, vomiting, felt nausea and dizziness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for felt nausea, as Unknown for vomiting, as Unknown for dizziness and as Not Applicable for exposure during pregnancy. Additionally, at time of reporting, the outcome of the pregnancy is unknown. Outcome of the pregnancy was reported as Unknown and fetal outcome was reported as Unknown. Documents held by the sender: none.
Body aches; Rapid heart rate; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2023, the patient received the 1st dose of Shingrix (intramuscular). On 2nd February 2023, less than a day after receiving Shingrix, the patient experienced general body pain and heart rate increased. On an unknown date, the outcome of the general body pain and heart rate increased were not recovered/not resolved.   It was unknown if the reporter considered the general body pain and heart rate increased to be related to Shingrix.     Additional Information: GSK receipt date: 02-FEB-2023 Reporter comment: The patient self-reported this case. The patient received first dose of Shingrix vaccine and started to feel body aches and rapid heart rate. The reporter did not consent to follow up.
Very high fever (106.7 highest) violent chills, headache, body pain, nausea x 2 days
The night of 4/7 I began to have a very bad acid stomach and started throwing up. I stopped throwing up on 4/8. I continue to have acid reflux presently. On 4/12 I began to have extreme pain in my neck and upper back which persisted for a couple of weeks. On 4/20 I began to have increasing burning pain in my upper left back in one spot that felt different than the muscle pain in my neck and upper back. On 4/24 I woke up to all the muscles in my back seized up and spasms in my neck and upper back constantly.  On  the morning of 4/25, I developed a rash from the spot on my left upper back that had been burning in the nerve. The rash is raised, red and has yellow pustules. It stretches across from my left upper back and wraps around my trunk and across my left breast. The nerve and muscle pain in my upper back was extreme. On  the afternoon of 4/24 I went to Lifespan Urgent Care and was diagnosed with Shingles and prescribed Valtrex. I have been on the medication for 3 days and the rash has spread but seems like it is starting to heal. The extreme pain in my back and neck muscles has started to subside but is still very painful. I am not able to get in to see my Physiatrist who treats my usual back pain until May 13.
Patient received 1st dose of Moderna vaccine on 3/19/21 (Lot # 014M20A on LD). Six days later, he had visited his primary care provider complaining about his left arm pit swollen lymph node. Per note, patient said initial reaction was soreness to the left arm. On 3/25/21 morning, he started to feel a lymph node in the left axilla.
Pt. started having soreness and itching on 5/3/15. Noticed some swelling. Pt. been feeling tired all weekend. Knot noted to left arm 1/75 in. from top of shoulder and 2in. wide.
Pt reported recvd 3 doses of hep B vax last Dec90. In Feb91 a routine lab screen showed abnormal liver fxn studies. No further details were provided.
Patient administered vaccine and remained in the vaccine clinic observation area for the recommended time period.  Patient at that time had no reactions and returned to her nursing unit.  Approximately 10-20 minutes after leaving clinic while working, patient developed: Right lip swelling,R scratchy throat,R tongue feels "tingley", No respiratory distress At onset of symptoms patient took her own benadryl 25mg po prior to re-presenting to clinic to notify staff of symptoms. Staff observe symptoms as listed above, again pt had no acute respiratory issues. Epinephrine offered to patient, refused by patient. Patient agreeable to repeat dose diphenhydramine, pt takes 12.5mg oral solution. Staff monitors patient closely, no worsening of symptoms and slight improvement noted within ~15-20 minute of presentation.   Patient leaves against medical advice from clinic due to a rapid response call for one of her patients.   Follow up with RN within an hour shows resolution of symptoms with diphenhydramine, no additional doses taken after the total of 37.5 mg
Caller reporting that a dose of PNEUMOVAX 23 was given to patient after its expiration date. Date of expiration: 8/18/2023, date of administration: 8/24/2023. Confirmed that the vaccine had never undergone temperature excursion.; This spontaneous report was received from a registered nurse concerning an unknown age and gender patient. The patient's concurrent condition, medical history, and concomitant medications were not provided.  On 24-AUG-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection 0.5 mL as prophylaxis (lot#: U035117, expiry date: 18-AUG-2023, route of administration, and anatomical location not provided) (expired product administered). It was confirmed that vaccine had never undergone temperature excursion.
Pt presented to pharmacy 3/28/18 at approximately 3:30pm inquiring about whether the reaction on her arm was normal for after receiving a shingles vaccine. Pt has severe redness, warmth, and mild swelling of the upper left arm. I advised her that it could definitely be a result of receiving the vaccine but that she should follow up with the physician that wrote the prescription so he could evaluate her condition and determine whether or not she should continue with the series.
Started having sore throat. Diagnosed with recurrent tongue cancer needing major reconstructive surgery.  Check up on September with prior 2020 cancer negative
sinus was very bad; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 13Feb2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took the vaccine, the second one, yesterday (13Feb2021), and was doing okay. However, the patient's sinus was very bad. The patient asked if it was okay to take decongestant pseudoephedrine hydrochloride (SUDAFED) or any of that, because he/she was told that you should not take anything except paracetamol (TYLENOL). The clinical outcome of sinus was very bad was unknown.  Information about lot number has been requested.
On 3/25 received small pox, anthrax typhoid vaccine. On 4/2 developed cellulitis at site of vaccination and non-specific generalized rash which began on the arms and travelled to thorax and legs, sparing hand/feet. Patient was vaccinated through work and seen at ER for the rash on 4/4/12.
Dont know what, was asleep. Woke up with slurred speech, taken by ambulance to hospital about 10:00. CT scan, lab work, MRI.
Around 12 noon on March 1, 2021 I began having full body muscle contractions. EMS was called and I was transported to hospital. They discharged me as all the test ran were negative for anything being wrong. The only thing I had done different was received the vaccines a couple days prior. This lasted for 2 days.
pt developed throat tightness post vaccine, no tongue swelling or difficulty breathing about 10 minutes post vaccine, patient remained for 45 additional minutes after administration of 25mg PO diphenhydramine which immediately resolved her symptoms. Pt experienced these symptoms after doses 1 and 2 and was recommended to finish the series as well as receive a booster by her allergist.
Case number PHEH2016US027834, is an initial spontaneous report received from a consumer on 25 Oct 2016. This report refers to a 45 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUCELVAX (batch number: not reported) at a dose of 0.5 ml intramuscularly on 10 Oct 2016. On 13 Oct 2016 (reported as in the same week), the patient experienced urinary tract infection. The patient had computer tomography (CT) scan (results unspecified) and was on antibiotics (unspecified) for his infection. The outcome of the event was reported as condition improving. The seriousness of the event was reported as serious (medically significant and disability) by the consumer. The causality of the event was not reported.
I was vaccinated on Friday 5/7/2021. I got a low fever on the same night and the day after. On Sunday morning 5/9/2021, I feel my inner lap parts are itchy. During the day, I found some rashes here and there over my body. Some rashes are swelling bumps. They are itches. I found my head skin under my hairs are itchy too. It was getting worse throughout the whole day.
Severe rash reaction started at my chest and face and you felt like its on fire and it was bright red and it itched, like sting bite no blisters. Got a steroid shot and in pill form for issues in my breathing. Went to urgent care, they straight to the doctor 21AUG2021. It comes and goes till to date.
Have not had a cold or flu since I stopped taking the flu shot; Initial information received on 27-Oct-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer) via social media.  This case involved a patient of an unknown age and gender who did not have a cold or flu since stopped taking the flu shot (Nasopharyngitis), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient has not had a cold or flu since patient stopped taking the flu shot (Nasopharyngitis).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event of nasopharyngitis was reported as resolving at the time of reporting.  There will be no information available on the batch number for this case.
Medical Assistant gave Trumenba instead of Prevnar during patient's well-child visit.  Low-grade fever started the morning after vaccine given otherwise the patient is doing good. Immunization Registry recommended reporting this event to Vaers.
Information has been received from a physician concerning a 6-month-male who on 20-MAR-2007 was vaccinated PO with the first 2.0 mL dose of Rotateq. Concomitant vaccinations administered on that same day included "other vaccinations". There was no other concomitant drug therapy. The physician reported that on 20-MAR-2007, the patient developed diarrhea. The patient was seen in the Emergency Room (ER) (not admitted to the hospital) and multiple clinic visits. The patient was never dehydrated. At both the ER visit and clinic visit it was determined that the patient had a mild case of diarrhea and the parents were instructed to give Pedialite to prevent dehydration. On approximately 03-ARP-2007, the patient's diarrhea resolved. The physician noted that she would not be administering any further doses of Rotateq to the patient. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of burning sensation in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 2nd dose of SHINGRIX. On 14th February 2019, 2 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and lymph node pain. On 15th February 2019, the patient experienced burning sensation and pain. On an unknown date, the outcome of the burning sensation, injection site erythema, injection site swelling, lymph node pain and pain were unknown. It was unknown if the reporter considered the burning sensation, injection site erythema, injection site swelling, lymph node pain and pain to be related to SHINGRIX. Additional details were provided as follows: On Tuesday, the patient received SHINGRIX. A day before reporting, the patient experienced that injection site was red and swollen, and her lymph nodes under her arm were painful. On the day of reporting, the patient had painful burning type of sensation all along the outer edge of her arm, armpit, and part ways down her left side. So far it was not a severe pain, but it was something that the patient had never experienced before, and since it happened after shot, the patient was a little concerned and just need some confirmation that she was okay. There was no rash along the site. The patient wondered if she was actually getting shingles due to the vaccine. The patient has not contacted her physician till the time of reporting. The patient asked if this was a reaction to the vaccine. she have not read about this reaction in the patient leaflet or on the medical websites. The reporter consented to follow up.
Joint stiffness; sweating; chills; vaccination site pain; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Joint stiffness), HYPERHIDROSIS (sweating), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced JOINT STIFFNESS (Joint stiffness), HYPERHIDROSIS (sweating), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever) and FATIGUE (fatigue). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, JOINT STIFFNESS (Joint stiffness), HYPERHIDROSIS (sweating), CHILLS (chills), VACCINATION SITE PAIN (vaccination site pain), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.            No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-062200 (E2B Linked Report).; Sender's Comments:  MOD-2021-062200:1dose
Fevers up to 101.6 every day from the first shot on 10/11/2021 until 2 days before the second shot on 11/8/2021 Fevers started again on 11/8/2021 and continue through today, 11/30/2021. Headaches up to 101.6 every day from the first shot on 10/11/2021 until 2 days before the second shot on 11/8/2021 headaches started again on 11/8/2021 and continue through today, 11/30/2021.
Information was received from a pharmacist on 17-NOV-2016. The pharmacist reported that an unspecified number of unspecified patients have experienced redness, swelling, pain and hardness at the injection site following administration of PNEUMOVAX23 (unspecified lot and expiration). The pharmacist reported that she had never seen the reaction spread in any of those patients. The pharmacist had no further information to provided regarding these unspecified patients. Additional information is not expected. This is one of several reports by the same reporter (MARRS # 1611USA009249 1612USA001909). Sender's Comments: US-009507513-1612USA001909: same reporter US-009507513-1611USA009249: source.
irregular periods/period again on 31Mar2021; early PMS type symptoms; Bloating; cramping; moody; Breast tenderness; had spotting/heavy bleed; This is a spontaneous report received from contactable consumer (Patient). A 30-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient had been off birth control for over a year and have had pretty regular periods. Patient got the first dose of the vaccine on 22Mar2021.  She already had period for March. Patient been seeing an uptick of information on the vaccine and irregular periods.  She started  (period) again on 31Mar2021 and had some early PMS type symptoms. She had bloating, cramping, was moody and breast tenderness. That Wednesday (31Mar2021) thru Friday she had spotting. She  had never had that before and afterward had some heavy bleeding until Sunday when it tapered off. Then on 12Apr2021 received the second dose of the vaccine. Everything seems fine now, but she was due to have my period again pretty soon. Events outcome for all events were recovered.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.