chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Several lymph nodes on her jaw/neck swelled up really big. She got a fever and was having headaches is when I noticed the lymph nodes a few days after the vaccine. After several days the fever and headaches went away. Her lymph nodes didn't go down though. After about a month they started to get bigger so I rushed her to the ER. They didnt know what caused the swelling, just told me to go back to my pediatrician after a couple weeks if they don't go down. We waited about 2-3 weeks and no change. I then took her to her pediatrician. I asked him if the HPV vaccine could of caused the swelling (with fever/headaches for a few days) since it happened right after the vacccine. He said, "there's no way the vaccine caused it", but didn't know what did. Just told us to wait a few more weeks and the swollen lymph nodes should go down. After about 3-4 weeks they went back down to normal. Since the doctor immediately denied it having any connection but now that I've researched and put it all together I know that's what caused it bc it was so soon after the vaccine.
Sore arm  at injection site; Onset of Fever, 100.4 °F; Chills; Upper body pain, aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th December 2022, the patient received the 2nd dose of Shingrix. On 8th January 2023, 11 days after receiving Shingrix, the patient experienced fever, chills and general body pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills and general body pain to be related to Shingrix.     Additional Information: GSK Receipt date: 09-JAN-2023 Reporter's comment: The reporter is the patient.  The patient received his second dose of Shingrix on right arm and experienced a sore arm at the injection site, and it was almost gone the next day.  The patient experienced a sudden onset of fever, chills, and upper body pain or aches.   The patient fever reached a temperature of 100.4 degrees (F).   These symptoms lasted for 4 to 5 hours.  The patient tested negative for COVID (twice).   The patient stated that he was feeling fine on the day of reporting. The reporter consented to follow up.
Patient developed dull R chest/axilla pain "around the time of vaccine".   On 5/11/2021 diagnosed with spontaneous pneumothorax.  s/p 10 day hospital stay including pleurodesis
small superficial clots; thrombophlebitis in his left leg; This is a spontaneous report from a Contactable Nurse (wife). A 76-Year-Old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date were not reported), dose 3, via an intramuscular route of administration, administered in arm on 29Sep2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and Concomitant medication(s) were not reported. Historical vaccines included first dose and second dose of BNT162B2 (Batch/Lot Number and Expiry Date were not provided), via an unspecified route of administration, on an unspecified date as dose 1, single and dose 2, single respectively for COVID-19 immunization. Reporter asked "does it matter which arm it got injected into", referring to the route of administration of the dose. The patient developed thrombophlebitis in his left leg and small superficial clots. The outcome of events was unknown.  The Lot number for the vaccine, [BNT162B2] was not provided and will be requested during Follow-up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  events Thrombosis and the suspect drug BNT162B2 cannot be excluded. 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.
Patient got first dose Moderna at Rite Aid and received second dose Pfizer at our clinic. Patient would not state that she received first dose of Moderna vaccine at all and was very resistant when questioned.
9/8/15 pt received immunization left arm deltoid. Pt complained of a "knot" feeling in arm 3 days post shot. About size of a quarter. No visible mark. Knot feeling lasted 7-10 days. Then went away without further complaints. Pt was concerned enough to document.
VACCINE EXPIRED 1/1/22. ADMINISTERED ON 1/6/22. NO HARM OR INJURY. NO ADVERSE EFFECT.
Swollen and reddened area from shoulder to antecubital fossa, hot to touch, urticarial rash. Contacted MD via video, began benadryl, ice and topical hydrocortisone cream.
Swelling to left thigh. ATARAX and hydrocortisone 1% cream.
Fever 102F, shaking chills, myalgia, headache, malaise from 6 pm to 4 pm the next day
It was a weird experience that's why I waited to see the doctor. I had a really pressured pain that started in chest area that felt like it traveled to my arm for a bit. Then at one point, it traveled to my leg. So I waited a few times before I saw my NP primary care. After the 3/4 time of it happening I ended going in to see my NP on June 3rd. They did an EKG and didn't find anything and referred me to the Cardiologist. I saw the Cardiologist on 9/27/2021 they did an EKG and didn't find anything and she was reviewed my family history. And there was no conclusion to it. The symptoms now changed and every once in a while I feel a sharp pain in my chest, it doesn't last too long. I've never had sharp pains before. I've had racing heart but that's a symptom of Hashimoto's.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 11:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:28 AM, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 84.82 Years.   Concomitant products were not provided.   On 28-Mar-2021, Excursion time was 10:00 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.   After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.   Treatment medications were not reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015 04:25, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.8 and 2.0 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Received influenza 11/30/00 and 1 week later, had right shoulder numbness that progressed into weakness, paresthesia, "started bumping into things". Also, had right side weakness in right leg "not as had in arm". Dx: Transverse Myelitis on 12/27/00. The 60 day follow-up states that pt last seen on 08/15/2001 and condition has improved (resolved).
no adverse event; 1 Separate, Improperly Stored VAQTA Dose was administered to 1 Corresponding Patient; This spontaneous report has been received from other reporter, regarding a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 10-FEB-2023, the patient was vaccinated with an improperly storage dose of Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection once as prophylaxis (lot number: W020525, which was determined to be valid, with an expiration date on 14-DEC-2023) (product storage error). The administered dose underwent a temperature excursion of 30.9 degrees Fahrenheit (F) for 4 hours and 30 minutes. No previous temperature excursion occurred, and no additional adverse event was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2302USA007648: US-009507513-2302USA007649:
1 mon p/vax pt exp periods of difficulty opening jaw lasting approx 1 min. This progressed until date of report when pt could only partially open jaw & exp pain moving jaw left & right. Pt saw MD 2/13/97.SEE comments.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 46-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (2 cases of shingles prior to SHINGRIX) and chickenpox (at 24 years of age). Previously administered products included ZOSTAVAX (received in 2011). On 11th June 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, 86 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient has had shingles twice in his life and the last shingles outbreak was the worst in terms of symptoms. Symptoms were not specified. The patient had denied permission to contact the physician. The patient requested anonymity for this report. The age was reported as 46 years, however it was unclear if indeed the patient was vaccinated at incorrect age. Clarification had been requested.
Patient experienced unusual movements involving arms and legs 4 days after vaccines were administered. Patient was admitted to the local hospital, where an EEG was completed that did not show any evidence of seizure. No antiepileptic medications needed per hospital. Patient was rechecked in PCP office 10 days after vaccines were given. Started on medication for GERD and plan to recheck in 4 days. Patient hospitalized for 1 day.
Immediately following vaccination, patient "saw black", became diaphoretic and pale. Patient was laid on floor with feet up on chair.   Vitals: 1600  BP 87/52 HR 52 98%  (laying 1602  102/68, 57, 98% (laying) 1604 103/74, 66, 100% (laying) 1605 111/69 73 100% (sitting on floor) 1609 106/69, 64, 100% (sitting in chair)  Pt was eating, talking and drinking water.  Symptoms resolved.  No further treatment needed.
2-3 days prior to getting the vaccine, I was experiencing my typical Irritable Bowel symptoms (cramping while defecating ).  Normally, if the cramping gets severe, I take one Hyosycamine Sulfate .0125 mg and the cramping stops within 10-15 minutes.   The morning after the vaccine , starting at 6 am, I had severe cramping...took one Hyosycamine Sulfate pill and the severe cramping did not ease for 2.5 hours. I called my primary physician and she felt that this intensity/duration  could have been connected to the vaccine.  I was not producing any feces during this event, just severe episodic cramping.  I also had the expected headache and chills.  I felt stomach discomfort for the rest of the day.  My doctor advised me taking the pill 3 times each day and two during an intense episode.  I took one more pill at 2:45pm.  I  had another episode  of severe cramping from 10:30-11:00pm ,  took two pills and then the cramping stopped and  resolved in some diarrhea (two movements).
unusually high number of covid infections in fully vaccinated employees; unusually high number of covid infections in fully vaccinated employees; This is a spontaneous report from a contactable physician. This physician reported similar events for 11 patients. This is the eighth of 11 reports. A patient of unspecified age and gender received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 23Dec2020 (lot number EH9899) and in Jan2021 (lot number unknown), respectively, both via an unspecified route of administration (age at vaccination unknown), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician stated they were seeing an unusually high number of COVID infections in fully vaccinated employees, with second dose plus two weeks, plus well over two weeks. All of whom received Pfizer and all of whom received their first dose from the same lot. The physician stated they may need an investigation, because they were seeing high viral loads in these individuals and symptoms. It was not right. All eleven individuals received their first dose from the same lot: EH9899. They did the standard dosage with the standard vanishing needle. The reporter was unsure if they kept the empty vials. The outcome of the event unusually high number of COVID infections in fully vaccinated employees was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 infection cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.,Linked Report(s) : US-PFIZER INC-2021392224 same reporter/ vaccine/ event, different patients;US-PFIZER INC-2021445810 same reporter/ vaccine/ event, different patients
Nurse at  clinic found to have given patient a dose of Pfizer 0.3 mL from a vial that was punctured and reconstituted on 10/26/2021. Nurse proceeded to put vial back in fridge after giving doses on 10/26/2021 and administered to this patient from same vial.  Nurse states pt. remained in clinic x 20 minutes with no reaction and no reports up to this date.
product expired on 5Mar2022 and was administered to a patient on 18Mar2022, with no reported adverse event; Initial information received on 22-Mar-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient who experienced product expired on 5mar2022 and was administered to a patient on 18mar2022, with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (Tenivac).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2022, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT with expiry date: 05-Mar-2022 (strength, dose, route, lot number and administration site) for Immunization (expired product administered) (latency: same day).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (product expired on 5Mar2022 and was administered to a patient on 18Mar2022, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event product expired on 5mar2022 and was administered to a patient on 18mar2022, with no reported adverse event.  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.
Exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose number:1, Lot number: Ew0153, Administrator route: Intramuscular, Administration date: 06Apr2021, Administration time: 10:45AM, Vaccine location: Left arm), administration date: 06Apr2021, for Covid-19 Immunisation. The following information was reported: FATIGUE (non-serious) with onset 05May2021, outcome "recovered" (2021), described as "Exhaustion". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient was not pregnant at the time of this report. The patient did not receive any other vaccine within four weeks prior to COVID vaccine. The patient did not receive other medications within two weeks prior to COVID vaccine. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Known allergies were None  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vomiting; dizzy; Initial information received on 11-Nov-2022 regarding an unsolicited valid  non-serious courtesy case received from a consumer/non-HCP.  This case involves a 61 years old female patient (51 kg) who had vomiting and dizzy after receiving influenza vaccine and while treated with treprostinil sodium [Remodulin].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included RIOCIGUAT (ADEMPAS); and MACITENTAN (OPSUMIT).  On 15-Aug-2019, the patient started taking treprostinil sodium 5.0 mg/ml Injection at a dose of 0.068 ug/kg via subcutaneous route  (lot - 2102128 and expiry date :31-May-2023) for Secondary pulmonary arterial hypertension.  In October 2022, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination  In OCT-2022 the patient had vomiting and dizzy (dizziness) (latency:  1 year 2 months approximately) following the first dose intake  of treprostinil sodium and (latency:  few days) following the administration of influenza vaccine  .  Action taken with influenza vaccine  was not applicable and unknown with suspect treprostinil sodium .  It was not reported if the patient received a corrective treatment for the events (vomiting, dizzy).  At time of reporting, the outcome was Unknown for the event vomiting and was Unknown for the event dizzy.
About 12 hours after I had severe chills and fever up to 102.2, muscle pains & very slight headache  Symptoms lasted 24hours EXCEPT for a feeling in my head that I have had when getting off my antideprssant--sort of fuzzy/shaken feeling. Wondering if it's making my meds for that ineffective.
Moderna 0.50ml given instead of Moderna 0.25ML (booster dose).  Client reported symptoms began the night of 11/19/21 with body aches. Four days later he reported sore throat, 6 days later report cold symptoms, cough, runny nose, no fevers and no more sore throat. Contact made 12/1/2021 with client reporting all symtoms have resolved, no new symptoms.
Very painful sores inside my mouth; This case was reported by a consumer via interactive digital media and described the occurrence of sores mouth in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced sores mouth. The patient was treated with valaciclovir hydrochloride (Valtrex) and magic mouthwash (nos) (Magic Mouthwash). The action taken with Shingrix was unknown. On an unknown date, the outcome of the sores mouth was unknown.   It was unknown if the reporter considered the sores mouth to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as per the vaccine indication. The patient had developed very painful sores inside my mouth.  The patient's primary care physician told me it was a side effect of the vaccine and put me on Valtrex and magic mouthwash.
About 11/15/2018 until today I experience an outbreak of shingles on my face, neck and upper chest (of all places!). Each day new spots appear blisters, red, swollen, some with puss at center, leaves scar. I had no prior history of shingles, herpes or any skin disorder. I did not/will not have 2nd dose. The expense of this overpriced drug, notwithstanding, I am claiming that I have been infected with shingles as a result of vaccine and results in dermatology expense and stress to cope. Nowhere and from no one have I been able to determine if these warnings have been made known to public. Had I known the risk, I would not have gotten the vaccine. I think the public should be told of this possibility!
PATIENT BRIEFLY FAINTED. CONSUMED 20 OZ SODA AND WATCHED FOR ADDITIONAL 15 MINUTES AND RELEASED.
Hives with itching about 4 to 5 days before it got better but still happening today (very minor).  Eyelids swelled lasted about 2 days. Left eye was worse, swelled completely shut. Both eyes had crusting.
PATIENT CALLED ON 07/06/2021 AND REPORTED HAVING FEVER, NAUSEA AND EXTREME FATIGUE STARTING THE NIGHT OF IMMUNIZATION. SHE HAD THESE ADVERSE EVENTS FOR 3 DAYS AND ONCE THESE ADVERSE EVENTS WENT AWAY, SHE STARTED ITCHING ALL OVER HER BODY. SHE HAS BEEN TAKING BENADRYL SINCE THEN BUT STILL THE ITCHING PERSISTS.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2016, the patient was vaccinated with a dose of ZOSTAVAX (route, dose, lot # and expiry date not reported) instead of a dose of VARIVAX. No adverse effects reported. It was verified that it was not product confusion. No further information provided. Additional information has been requested.