chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse Event - Double vision. - Diplopia 6th nerve palsy on my right eye.   Treatment -  Went to see a doctor in my current location and doctor did not give any medicines , but advised MRI.  I did not go for MRI due to personal reasons.  After consultation with doctors , I took Homeopathic and Ayurvedic medicines  everyday.   Outcome - After one and half month , my right eye started moving , but it took almost one more month for complete movement, but right eye movement was not in sync with left eye, so there was a double vision at few angles towards right. After one more month, complete NORMAL vision is back... It took almost three and half months to get back to normal... 1st Dec 2021 onwards , my vision is good
This is a spontaneous report from a contactable nurse practitioner via a Pfizer representative. A male patient received PREVNAR 13 (lot J49846, expiration date 01Feb2016) on 18Nov2014, at 3:53 PM, as 0.5 ml single dose, intramuscularly to the left deltoid. Medical history included liver transplant. Concomitant medication included an unspecified anti-rejection medication. The patient got a rash over the entire body that was itchy and red within a couple days after receiving the vaccine; onset date of rash was 19Nov2014. The patient visited the doctor due to the rash; there was no hospitalization for the events. Representative believed the patient was still experiencing the adverse event because he had to go back and get some more cream that was provided. As of the reporting on 18Feb2015, the outcome of rash was reported as recovered on an unspecified date. The physician reported that it was unknown if the Pfizer product had a causal effect to the adverse events. Follow-up (05FEB2015): Follow-up attempts completed. No further information expected. Follow up (18Feb2015): New information reported from a contactable physician includes: suspect product data (lot J49846, expiration date 01Feb2016; administered on 18Nov2014, at 3:53 PM to left deltoid), detailed event description (onset date of rash was 19Nov2014), outcome (rash recovered) and causality (unknown). Follow up attempts completed. No further information expected.
I received 1st dose of Pfizer covid-19 vaccine on 12/26/2020 w/ no side FX. I received 2nd dose of Pfizer covid-19 vaccine on 1/16/2021 with no immediate side effects. On 1/26/2020 at 10:AM I started experiencing cold chills with uncontrollable shaking and fatigue. I took ibuprofen 800 mg and went to bed. I woke up on 1/27/2020 at 7:AM and felt fine.
5cm erythematous,edematous, tender,warm nodule to site of injection.  Ice immediately improved symptoms and decreased edema.
Super painful arm; night sweats; headache/intermittent headaches; super achy; chills; pregnant; fatigue; This is a spontaneous report from a contactable female nurse. A 31-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number:  EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation. The patient medical history included seasonal allergies, acid reflux, headaches, IBS. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), minerals nos, vitamins nos (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC) and allergy shot. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) via an unspecified route of administration, administered in arm left on 29Dec2020 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation and experienced headache, night sweats, achy, exposure during pregnancy and chills.  It was reported that patient experienced 12 hours post injection that was on 20Jan2021 at 13:00, super painful arm, night sweats, headache, super achy and chills and the 2nd night post that was on an unknown date in Jan2021, continued with night sweats and fatigue and intermittent headaches with achiness. The patient last menstrual period was on 19Dec2020. The patient was 4 Weeks pregnant at the onset of the event. The patient was due to deliver on 25Sep2021. The patient did not receive any treatment for the events super painful arm, night sweats, headache, super achy, fatigue and chills. The events were reported as non-serious. The outcome of the events painful arm, night sweats, headache, super achy, fatigue and chills were recovered on an unknown date Jan2021 while for other event pregnant was unknown.
Headache, Myalgia, Fever, NauseaVomiting, Fatigue, Chest congestion and cough. Narrative:
Arm was sore; couldn't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were resolved with sequelae.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were received as follows: The patient after 1st dose of Shingrix experienced arm sore and she could not lift it for a couple days. The patient did not consent to follow up.
Patient's mother reports that approximately between April - May of 2016 the patient began to experience hip pain, elbow pain, swollen lymph nodes, lost 20 lbs. Over the winter into 2017 mother reports the patient began to experience chronic fatigue, chest pains, memory loss, forgetfulness, irregular menses, irritability, hand tremors, and a seizure disorder. PLEASE NOTE THE PRACTITIONER COMPLETING THIS FORM IS NOT THE SAME AS THAT WHO ADMINISTERED OR ORDERED VACCINE. THE PRACTITIONER TREATING THE PATIENT DURING THIS SPAN OF TIME HAS SINCE LEFT THE ORGANIZATION.
Case number PHEH2013US018411 is an initial spontaneous report received from a nurse on 28 Aug 2013. This report refers to a 13-years-old male patient. His medical history and concomitant medications were not reported. His vaccination history included administration of Tdap (other manufacturer, batch number: not reported) following which he had redness at the injection site (TDAP reaction was not severe). He was vaccinated with MENVEO (batch number: not reported) on 14 Jun 2013 at 11:30 am. It was reported that later that afternoon he went for swimming and noticed redness and swelling at the vaccination site. His mother gave him an unspecified antihistamine. Two days later, the vaccination site swelling became progressively worse and it turned to a whelp and was swollen below the elbow. Whelp was hot, red and painful. He was taken to the emergency room and was treated with high dose antibiotics for suspected cellulitis. He had to have the dose of antibiotics reduced and the events eventually improved and symptoms subsided. His physician referred him to an allergist. Upon research, the allergist determined that the reaction was probably not cellulitis, but rather a "diphtheria-toxoid reaction". The outcome of the event was reported as complete recovery. The seriousness and causality were not reported.
Bruising at site, post vax, on 6/19/01. Reports of pain in left arm since shot was given.
no adverse effects; The patient was administrated with one dose of an improperly stored vaccine VARIVAX (9.3 F); This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided.      On 05-FEB-2019, the patient was administrated with one dose of an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were not reported) (lot # R031626, Expiration Date: 01-NOV-2020) subcutaneously for prophylaxis. There were no adverse effects. The stored temperature was 9.3 Fahrenheit (F) for 45 minutes and the data logger was involved. There was no previous temperature excursion. It was used to reconstitute sterile diluent (strength, dose, frequency, route, lot # and expiration date were not reported). The storage of sterile diluent was unknown.
p/vax pt swelling of rt & lt eye; gave pt prelone at MD office; also gave prednisone; went home p/tx
Altered mental status and generalized weakness. Discharge summary states encephalopathy. msv Medical records state abnormal vision, palpitations, anxiety, speech disorder. msv.
Developed a Fever, Chills, Cough and nausea on 11/28. Went to ER on 12/01/21 and tested positive for Covid 19. Sent her home with no medications or oxygen. Developed severe nausea and bad diarrhea from 12/02/21 to 12/05/21. Went back to ER and was admitted for Covid Pneumonia on 12/05/21. Also developed bacterial pneumonia. Patient is currently still in the Hospital.
Blood clot in urine; On 01Apr2021, he received first dose/On 01Aug2021, he received second dose;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4242343-00.  A 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Aug2021 (Batch/Lot number: unknown) at the age of 77 years as dose 2, single for covid-19 immunisation; leuprorelin acetate (LUPRON DEPOT) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. It was unknown if he was enrolled in a COVID-19 vaccine trial. Vaccination history included: Bnt162b2 (Dose 1, Route of administration: Intramuscular), administration date: 01Apr2021, when the patient was 77 years old, for COVID-19 Immunization. The following information was reported: HAEMORRHAGE URINARY TRACT (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Blood clot in urine"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 01Aug2021, outcome "unknown", described as "On 01Apr2021, he received first dose/On 01Aug2021, he received second dose". The action taken for leuprorelin acetate was unknown. The patient had blood clots in urine and was hospitalized several times since end of last year 2021. Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) was also considered suspect. Adverse event information provided by the patient was related to COVID-19 vaccine.   Causality for LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT)  The reporter's causality for the event(s) of blood clots in urine was not provided. opinion is that the event of blood clots in urine is not assessable.  Causality:  LUPRON DEPOT (LEUPROLIDE ACETATE DEPOT)  1) Blood clot in urine (Haemorrhage urinary tract) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable Dechallenge : N/A  Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN)  1) Blood clot in urine (Haemorrhage urinary tract) Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Did event abate after stopping drug? NA  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal association between the event and 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.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's medical history or concurrent conditions were not provided. On 25-AUG-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (intramuscularly, lot # K004542, expiration date 25-AUG-2015). Concomitant medication was not provided. This pharmacist also noted this was only dose of PNEUMOVAX 23 this patient had ever been administered. No adverse effect reported. Additional information has been requested.
1/19/2021 1110 accompanied wife for her scheduled covid vaccine appointment. Asked to see nurse and showed nurse rash on abdomen. States he had his vaccine on 1/14/2021. Patient taken to private observation area for further evaluation.  States he played golf on Friday 1/15/2021 in the morning and took a shower that afternoon and noticed the rash. States he noticed his neck and back was itchy while playing golf but became very itchy after shower. States he couldn't see his back or the back of his neck. Denied having any rash or itching at vaccine site. States he didn't notice the rash on his abdomen until Sunday 1/17/2021. He had played golf again in the morning. States he has been newly diagnosed with eczema and was given a cream for it. Denies using the cream. Patient displayed his lower legs and states, I have a mix of eczema and rash. Has red pinpointed dots and multiple scaly crusty mild red areas on bilateral lower legs, across abdomen, and upper back region. He doesn't know if it is from his Moderna shot or from his eczema. States he started taking Benadryl on Sunday night 1/17/2021 - taking two 25 mg tablets once a day. Denies ever having throat or facial itching. Denies arms itching or soreness. Denies having any trouble swallowing or respiratory difficulties. Denies ever having hives or swelling. Noted same scaly, crusty areas across patient's forehead. States the rash on his shoulders have diminished.  States on day of vaccine did not have any itching or rash.  Advised to check with dermatologist treating skin cancer and eczema and to discuss with physicians if there is any possibility of rash from meds. Advised to seek medical attention also from PCP.  Patient states he wants to get the second vaccine. Advised to seek medical attention and what PCP recommends. Advised if he does come back for second vaccine to let us know of the rash and he would be observed longer.
CHILLS; LIGHT HEADACHE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-202116:30 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and light headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headache and chills was not reported. This report was non-serious. This case, from the same reporter is linked.
1st dose of Twinrix in 11Oct2021, late for 3rd; 1st dose of Twinrix in 11Oct2021, 2nd dose in 07Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 11th Oct 2021).   On 7th January 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient did not receive the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:24-May-2022 Reporter's Comments: A pharmacist reported that a patient received 1st dose of Twinrix on 11th October 2021, was late for 2nd dose given on 7th Jan 2022, and was late for the 3rd dose at the time of reporting.  No symptoms reported. The reporter consented to follow up via mail. Additional Supportive Information: The patient received 1st dose of Twinrix on 11th October 2021 and received 2nd dose on 7th Jan 2022, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination
not feeling too well; not feeling good; chills; bone in her body is hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting). At the time of the report, VACCINATION COMPLICATION (not feeling too well), FEELING ABNORMAL (not feeling good), CHILLS (chills) and BONE PAIN (bone in her body is hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Roughly 5 hours after the patient received her first Pfizer Covid-19 Vaccination she had prominent signs of chest tightness, shortness of breath, and bronchospasms that are normally controlled by her Budesonide nebulization treatment and Arformoterol. One week later she had very painful heartburn and headaches located in the forehead. Because of these symptoms she had to go to the Emergency Room.
About an hour after his shots his leg started to swell and within 24 hours it was twice it's size, bright red and it could not be touched without causing pain. He had inconsolable screaming for about 72 hour period, from the moment he woke up to the time he slept. Very lethargic and was not interested in eating and had to be completely tube fed. He also began having clusters of infantile spasms. All of this lasted roughly a week, with the seizures lessening over an additional weeks time. He is severely delayed at this time but as of right now I have no idea if he has sustained permanent neurological damage due to the seizures.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 06-SEP-2017, the patient was vaccinated with improperly stored PROQUAD lot # N012490 and expiration date on 17-OCT-2018, subcutaneously (dose was not reported) for prophylaxis; which was reconstituted with properly stored sterile diluent (MRK). The doses of PROQUAD were exposed to a temperature excursion of 15 degrees Fahrenheit (°F) to 46 °F (19°F) during a time frame of 10 minutes which was detected by the data logger. There was no prior temperature excursion, no adverse events were reported and no product quality complaints were present. This is one of the two reports received from the same source. Sender's Comments: US-009507513-1709USA011998.
Broke out in rashes all over my chest, belly, and back so far; This is a spontaneous report from a contactable consumer. A 31-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No covid prior vaccination. The patient previously received first dose of bnt162b2 on 28Jan2021 for COVID-19 Immunization. The patient experienced broke out in rashes all over my chest, belly, and back so far on 25Feb2021 17:00. Treatment included Benadryl. Outcome of event was not recovered. No covid tested post vaccination.
Vaccine leaked out of syringe while needle was in arm, luer lock connection was loose. Pt did not receive any vaccine, another dose given.
tested positive for Covid yesterday; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid yesterday) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and COVID-19.    On 18-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Oct-2022, the patient experienced COVID-19 (tested positive for Covid yesterday). At the time of the report, COVID-19 (tested positive for Covid yesterday) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Oct-2022, SARS-CoV-2 test: (Positive) Positive and (Positive) Positive. On 23-Oct-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant drugs were not reported. It was reported that patient had total 5 doses and all was of Moderna. It was also reported that for patient it was the third time of COVID infection, most recent being the second time in 5 months. Patient was isolating at home with chest tightness, sneezing, congestion, runny nose, headache, fatigue and dull sense of taste. Patient had two rapid tests and a PCR test on 22-Oct-2022.  Treatment medications were not provided.
Patient presented with 4 weeks of episodic jaw pain following the JJ vaccine. Presented acutely to our hospital w/ substernal chest pain, found to have STEMI on EKG. Taken to the cathlab, no evidence of obstructive coronary disease. After cath, patient went into progressive cardiogenic shock. Repeat Left heart cath showed no evidence of obstructive coronary disease but RHC indicative of cardiogenic shock. Cardiac MRI consistent w/ multifocal infarcts. Further ischemic workup negative. Autoimmune workup negative.
Narrative:  Patient received the first dose of COVID19 vaccine in August 2021. On 1 September, the patient tested positive for COVID 19 and was hospitalized with respiratory failure, fever, and COVID pneumonia. The patient received treatment and was discharged to Rehab on 30 Sep 21. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Persistent swollen lymph nodes in armpit region on both left and right sides. Swelling causes notable persistent pain and has interrupted normal sleep pattern.  No treatment sought.