chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Between 5 - 7:00 AM.  My Father woke up to go to the bathroom, at that time he recalls he could not locate his left slipper.  He had experienced a stroke and his left side was not functioning.  My Mother figured it out and called 911 and he was at the hospital.  They could not determine if he fit in the 3 hour window for the Blood Clot medicine, so they did not administer it.  He was kept in the hospital and observed, then moved to rehab.
Initial report received from a healthcare professional on 30 June 2011. It pertains to 1 of a cluster of 2 patients whom the reporter noted had experienced adverse events following receipt of ADACEL. The event for the other patient is captured in 2011-03968. A male patient received an injection of ADACEL (lot number C3899AA). The following week, he returned to the office with "mild cellulitis". Outcome was not reported. Follow-up information was received from the healthcare professional on 11 August 2011. The patient was 61 years old, and had a history of left epididymitis, hyperlipidemia, splenic flexure syndrome, GERD, hyperplastic polyps colon, dysphagia, anal fissure healed, mild diverticulosis, IBS, chronic prostatitis (Koster), and hypertension (April 2008). Medication allergies included penicillin, ANUSOL, PREVACID, INDAPAMIDE, Amlodipine, and Clonidine. ADACEL was administered in the right arm in June 2011. One week post-vaccination, he developed soreness in the arm and redness at the injection site, which then increased and extended slightly down his arm. Upon exam, his right deltoid was slightly extended distally, with mild swelling, redness, and warmth. He was diagnosed with cellulitis, and treated with BACTRIM DS 1 tablet BID by mouth. He was instructed to return to the office if symptoms did not improve within 3 days. The event subsequently recovered on an unspecified date. Documents held by sender: Office note.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 09:18, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
On Nov 1,2019, I came in contact with a bat in our house. I went to  ER and was given 5 IM Rabies shots( left arm, left thigh, left hip,right thigh, right hip) and 1 IM rabies vaccine( right arm).I received subsequent IM Vaccines on Nov 5,10,17. Alternating shoulders. On, or around, Dec 2,2019, I started experiencing severe pain in my left shoulder with marked limited range of motion. After a few days, I took a week course of Diclofenac with some improvement. A week later, the pain returned, now in both shoulders/upper arms. It was much worse. I called my doctor, thinking it was from the vaccines. She had me go to PT for evaluation who confirmed that was the likely cause. I am now nearly 2 months after the first injections and am better, though I still have  weakness in my arms and some residual pain. I am still doing PT. If I am not better in 2-3 more weeks, I will need to see an Orthopedist for more treatment. I am a retired MD.
Approximately 30 minutes after vaccine administration patient began to experience constriction in throat and burning sensation in palms. Patient went to ER and was given 3 days of prednisone and famotidine.
pt has been approx 30 to 45 mins since vaccine administration & parents brought pt in red all over body; no s/s of fever is not fussy; LMD recommended give DTP & HIB separately;
p/vax pt devel an inj site rxn characterized by a 2 inch by 4 inch area of redness, induration & swelling;pt recovered; This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Acel-Imune lto 462-312. Follow-up information from the physician on 23-Aug-1999 indicated that the patient developed a "wheal" at the Acel-Imune injection site measuring 3cm by 2cm. She was treated with Cefzil for 10 days and recovered.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020) and (batch number D3G59, expiry date 25th April 2020). Previously administered products included ZOSTAVAX (patient had received ZOSTAVAX a few years ago). On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 18th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria disability), injection site swelling (serious criteria disability) and injection site pain (serious criteria disability). On 20th April 2018, the patient experienced blood in urine (serious criteria disability) and urinary tract infection (serious criteria disability). On an unknown date, the outcome of the injection site erythema, blood in urine, urinary tract infection, injection site swelling and injection site pain were not recovered/not resolved. The reporter considered the injection site erythema, injection site swelling and injection site pain to be related to SHINGRIX. The reporter considered the blood in urine and urinary tract infection to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient had redness and swelling at the injection site. The patient was seen at the physician office today due to her whole bicep area being swollen and red. Three days after receiving vaccination, the patient experienced blood in urine and diagnosed with a urinary tract infection. The physician did not believe the blood in the urine and the urinary tract infection were necessarily related to the injection.
she had with the first dose was a sore arm that went away after 2 days; Painful urination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) and DYSURIA (Painful urination) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine). Concomitant products included LOVASTATIN, GABAPENTIN, DULOXETINE and HYDROCHLOROTHIAZIDE, SPIRONOLACTONE (ALDACTONE 50 HCT) for an unknown indication.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DYSURIA (Painful urination). On an unknown date, the patient experienced PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days). At the time of the report, PAIN IN EXTREMITY (she had with the first dose was a sore arm that went away after 2 days) had resolved and DYSURIA (Painful urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details provided.   This case was linked to MOD-2021-316145 (Patient Link).
Pt received Hepatitis A vaccine on 10/26/12 at 455pm. The pt. awoke the next day with itching, rash on (L) arm & lip swelling. Was seen at health center. Was given Prednisone. Patient is a 17-year-old female. NAD, not toxic. Left posterior upper arm with fine excoriations. No rash on neck, face, back UE or LE X2. Slight swelling of midline upper and lower lips, no macroglossia, throat widely patent.
Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old female patient who was received a 0.5 ml dose of ACT-HIB (Batch number: UI913AAA, expiration date: 14-Nov-2019, frequency once, site of administration: left thigh and route was not reported) on an unknown date. Concomitant medications included was KINRIX, INFLUENZA VACCINE and PREVNAR. The patient's medical history were not reported. It was an actual medication error due to inappropriate reconstitution technique as patient received ACT-HIB reconstituted with sterile water instead of saline water. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 21.79.  Concomitant products were not provided.  On 15-Apr-2021, for excursion time 9 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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 Fisher brand 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.
right after shot given. Noticed instead of bivalent pfizer  vaccine pt received Primary dose. pt told about side effects and how to treat. Still wanted bivalent dose so received another dose.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and gender. No information on patients medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (dose, dose number, route of administration, lot# and expiration date were not reported). No information on patients conconcomitant medication was provided. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mom called office 10/19/2007 4:00pm to tell staff that he baby was covered in a rash from head to toe.
Over a period of 8 wks. Painful rash on arms, neck & chest, itchy, low grade fever 99-100. MEDROL & antihistamine, ELIDEL cream, Hydrocortisone Valerate cream. Vasculitis - 20 day course of Prednisone 20mg (80, 60, 40, 20, 10), ELIDEL cream, Hydrocortisone Valerate cream.
Initial vaccine sore arm only; 2nd shot and one booster triggered same event: chills, headache,  nausea, dry vomiting.  However, although I suffer migraines, this was different - brain felt like it was on fire and experienced a repeating cycle of passing out, throat closed, jerked alert while choking, dry heave,, passing out - over and over again without any ability to fight it.  Deeply concerned about choking to death.    I?ve had flu, been hospitalized from strep+e Coli, and had MERS in Dec 2012.  This was entirely different.  Cycle stopped around 10-11 hrs 2nd vaccine but 13 hrs with booster.  Concerned but unconfirmed neural adversity.  However, if needed, willing to provide 2018 MRI record but would need to obtain current MRI for comparison.
The night /p vax, pt's parents noted seizure activity. Was assoc /w a T 104.5.  Taken to Hospital, normal exam, the following day, no evidence of local infection
Soreness in arm; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in arm/pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. No adverse events reported to the first dose of the vaccine.   On 24 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 24 Feb 2021, the patient experienced the event soreness in arm following administration of vaccine.  No treatment information was provided.  Since patient received both the scheduled doses of the vaccine action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event soreness in arm was not resolved.
5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from a contactable consumer or other non-health care professional via Pfizer sponsored program. A contactable consumer reported similar events for five patients under the same suspect product. This is third of five reports. A patient of unspecified age and gender received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiration date: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that 5 people in his church got COVID-19 after being vaccinated with Pfizer vaccine. The reporter asked if, after 6 months, he should get a booster dose, or how long should he wait. The reporter stated that he got his first 2 doses of the Pfizer Covid-19 vaccine on 01Apr2021 and 30Apr2021, respectively. He asked how effective those doses are after 6 months. He mentioned that he had temporary side effects after those doses but did not specify what they were. The patient asked whether he should wait to go to the dentist until he gets a booster. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Muscle pain and weakness in upper left are and left shoulder.  Continual pain whenever the arm is used.  Very difficult to do simple things such as lifting a blanket or pillow off the bed.  This pain was not occurring prior to the shots.
IDIOPATHIC SUBCLAVIAN DEEP VEIN  THROMBOSIS Narrative:  IDIOPATHIC SUBCLAVIAN DEEP  VEIN THROMBOSIS  Other Relevant History:
It was a slight hangover about a day or 2 after the first 2 Covid shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: GP6855) at the age of 41 years as dose 1, single and administered in arm left, administration date Apr2021 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: he does suffer from vertigo and had had it in the past. The patient took concomitant medications. The following information was reported: HANGOVER (non-serious) with onset 2021, outcome "unknown", described as "It was a slight hangover about a day or 2 after the first 2 Covid shots".  Additional information: He states he was a little hung over for a day or 2. He was able to work and drive and function. It was normal and there were no other issues.   No follow-up attempts are possible. No further information is expected.
severe dizziness w/nausea but no vomiting;s/s of vertigo;no h/a;
Patient reports sore arm, warm to touch patient on doxycycline for another infection told patient to ice and take MOTRIN if worsens contact primary care provider.
sore arm; crying uncontrollably; rage/ wanted to throw something through the wall; episode of depression; blissfulness; high energy as if he could run a marathon; emotional bouts; dizziness; orthostatic changes from laying in bed to sitting up; pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control; sounds like a neuro reaction; can't stand up; This is a spontaneous report from a contactable Physician. This Physician (Patient's father) reported.  A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Formulation: Solution for injection), Lot number was unknown, via unspecified route of administration on 01Sep2021 15:00 as dose 2, single for covid-19 immunization. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, for Covid-19 immunization and experienced only a sore and no other side effects. The patient medical history and concomitant medications were not reported. On 02Sep2021 the patient experienced Sore arm, dizziness, orthostatic changes from laying in bed to sitting up, pseudobulbar reaction/ like a pseudobulbar like emotional lability that he can't control, sounds like a neuro reaction, can't stand up, crying uncontrollably, rage/ wanted to throw something through the wall, episode of depression, blissfulness, high energy as if he could run a marathon, emotional bouts. On an unspecified date in 2021, the events emotional bouts, high energy as if he could run a marathon, blissfulness, episode of depression, rage/ wanted to throw something through the wall, crying uncontrollably were recovered. At the time of reporting, the outcome of the events can't stand up, sounds like a neuro reaction, dizziness and sore arm were unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during fol-low-up.
pt recvd vax; felt sick to stomach; slumped over then fell backwards; started jerking, moaning, eyes rolled back, lasted 25 seconds; to hosp; pt adm x 2 days; pt was running low grade t 99.9-100.8 during incident; pt nl now;
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of GARDASIL (lot # L007560, expired date as 15-JUN-2017, route, dose, dose number and strength were unspecified) that were improperly stored. No adverse effects were reported. This is one of the two reports that received from the same source. Additional information has been requested.
Pt experienced syncopal event 4 min after immunization received. Slight movement noted of left arm and left leg for 15 seconds while syncopal event lasted. Pt regained consciousness 30 seconds after syncopal event started.  Applied cold towel to forehead and cheeks, Pt maintained a pulse during syncopal event.
Patient received the PNEUMOVAX vaccine and the FLUBLOK vaccine in the R deltoid on the morning of 9/24/18. By that evening she complained of body aches, fatigue, temp 100.4 F, arm soreness, weakness, neck and shoulder pain. Reports today 9/25/18 continued significant pain, difficulty lifting R arm, fever resolved.
Case number PHEH2015US001210, is an initial spontaneous report from a nurse received on 14 Jan 2015 with a follow up information received from the nurse on 18 Feb 2015. This report refers to a 23 years old female patient. She had unspecified medical history. No concomitant medication was reported. Her vaccination history included administration of previous doses of MENVEO (batch number: not reported) which was well tolerated. It was reported that the vaccine mixing was incorrect and she was administered only 0.5 ml MenCYW-135 liquid component of MENVEO (batch number: M14080) intramuscularly without being reconstituted with MenA lyophilized conjugate on 09 Jan 2015 at 10:00 (booster dose). No adverse event was reported following the administration error. Follow up information received from the nurse on 18 Feb 2015: Updated vaccination history and narrative.
exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 29-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 10-Dec-2020 and the estimated date of delivery was 16-Sep-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Ultrasound foetal: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.