chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red, hot, painful, and very itchy lump near injection sight. Around 9pm the patient applied heat, and then at 10:20pm applied ice. Upon waking up at 7:45am the arm was only painful when touched and there was no soreness. The hard lump can still be felt at 12pm on 07/30/2022. The itching comes and goes, but seems reactive to when the arm is touched. Patient has been able to go about day normally, trying to ignore boughts of itchiness.
At 3:00 p.m. the following day after the injection my temperature started to rise. My chills were so severe that I was unable to sustain being upright. Just rolling over in bed caused severe shaking. My temperature of 102 lasted for 15 hours.
Child was given the following vaccines; PEDIARIX, Hib, PCV-13 at 9:16 am on 7-28-14- left w/o adverse reaction but when child got home 1/2 hr later developed hives on body and was brought back to doctors office. Dr was made aware and given BENADRYL at 9:37 am.
After leaving the site, my left side of face went numb. Still slightly numb 2 days later.
Information has been received from a pharmacist concerning a 69 year old male consumer who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, sometime after receiving the vaccination the patient developed shingles on an unspecified date. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
started 28OCT98 rash covering torso-neck to knee, bright red raised red areas 1/8", itching still cont w/rash but dec severity;
Injection site got red, hot and itchy; Injection site got red, hot and itchy; Injection site got red, hot and itchy; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, Injection site erythema, injection site warmth and injection site pruritus.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection. On 9 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the events, injection site got red, hot and itchy.  Treatment details included Antibiotic, antihistamine, cortisone cream.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of events, injection site got red, hot and itchy was unknown.
Bitter taste in her mouth which is not resolved; weakness; Felt tired/ fatigue; This case was reported by a consumer via call center representative and described the occurrence of taste bitter in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID19 Vaccine (received in February 2021).   On 2nd June 2021, the patient received the 1st dose of Shingrix. On 3rd June 2021, 1 days after receiving Shingrix, the patient experienced weakness and fatigue. On 4th June 2021, the patient experienced taste bitter. On an unknown date, the outcome of the taste bitter was not recovered/not resolved and the outcome of the weakness and fatigue were recovered/resolved.   It was unknown if the reporter considered the taste bitter, weakness and fatigue to be related to Shingrix.  Additional details were provided as follows: The reporter was the husband of the patient. The age at vaccination was not reported. The patient had her first dose of the Shingrix vaccine and the next day she felt tired and weakness. On the morning of day of reporting (Friday), she felt better but had a bitter taste (latency 2 day) in her mouth which was not resolved. The reporter declined to provide demographic information and declined follow up with physician. The reporter did not consent to follow up.
Left arm broke out in a red rash that was incredibly intense, rash was also present in the right arm and across the front of chest down to waistline. The itching was felt in all areas that were not paralyzed. Over the next few days the left arm had pimple like projections with puss coming out of them. the same thing occurred on my chest and some of these bled. The reaction was a similar reaction to poison ivy or poison oak that i remembered from the past. I also tried using some Calamine lotion on the skin.
shingles; other zoster-related conditions; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 26-SEP-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, and route not specified) for the long-term prevention of shingles and zoster-related conditions, at a physician's office. Subsequently, on an unknown date, the patient was treated by a physician for shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of those injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events was considered as not recovered/not resolved. The reporter considered the herpes zoster and ill-defined disorder to be related to Zoster Vaccine Live (ZOSTAVAX).
Around 2 PM I started coughing, then low grade fever, followed by aches, chills, tired. Went to bed around 7:30 PM, around 1 AM fever broke, and slept until 6:30 AM.
Pt rec'd first Dtap on 4/20/04. Pt became pale, fever, congested, fussy with in 48  hours of shot then admitted on 4/26/04 for presumed bronchiolitis. In retrospect she was having difficulty handling her secretions and was possible aspirating. She had a long progressive course of prolonged O2 need, hypotonia, inability to orally feed, G Tube placement to protect her airway.  01/29/2007: MR received from a 2 night hospitalization of 04/26/2004 for cough with hypoxia.  Mild cough noted by parents beginning ~24 hours after 2month vax. Seen in ped. office on 4/26/2004 where pulse ox was noted to be in the high 70's to low 80's on room air.  She was placed on O2 and admitted to the hospital. PE: Significant for coarse expiratory rhonchi and a deep, chesty sounding cough. Otherwise WNL.  O2 requirements decreased with vigorous suctioning however, child continued to need supplemental O2 from 100-200 cc/min.  She was discharged home on supplemental O2. Discharge DX: 1) Presumed Viral Pneumonitis. 2) hypoxia.  02/19/2007: Medical records received from PCP documenting 2+ years of F/u for truncal hypotonia and dysphagia which developed following 2 month vax. in April 2004.  The baby continued at home on O2 and NG tube feeding for approximately 12 weeks.  She was admitted again  5/26/2004 for an aspiration pneumonia.  Principle diagnosis: Chronic aspiration. Secondary Diagnosis: Aspiration pneumonia. Neurology note from 8/27/2004 with discussion of ADEM-Acute Disseminated Encephalomyopathy as the cause of the truncal hypotonia and dysphagia.  G-tube was placed 10/7/2004.  Assessment from neuro note of 10/29/2004 is "Undefined focal neuromuscular disorder". Truncal hypotonia resolving/resolved by 11/17/2004, however persistant cricopharyngeal dysfunction and dyspahgia remain.  Last recorded Neuro F/U  (5/16/05) discusses the possibility of an isolated bulbar form of Guillain Barre' syndrome. By age 2 years, (2/24/06) child was taking po and only having G-tube feedings at night. Dyspaghia was now considered resolved and G-tube was removed shortly after that visit per TC to MD. Also, no F/U with neurologist after 5/2005.
Patient said was fine after the 15 minutes he waited in the store. He said a few hours later he was very weak and lightheaded and almost passed  a frew times on his way to the store. He said that it was like a very bad flu. He said it lasted 2 to 3 days. We instructed him to follow up with his doctor.
Pt became incoherent and son described he acted as though he had a stroke. EMS said pt's blood glucose was 20 and required a 2 night hospital stay until his glucose returned to normal levels.
Knees locked up a couple of hours after shot and lasted till the next day.  Weaken condition, sweats and fever.
This spontaneous report as received from a medical assistant referring a male patient of unknown age who on an unspecified date was vaccinated with an expired dose of M-M-R II (lot # 667737/0603Z (Expired date 23-APR-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported.
Fever of 102, aches, chills, fatigue and other flu like symptoms for 48 hours
patient was not prescribed IPOL but was prescribed TB skin test and received IPOL in error with no reported adverse event; IPOL was administered intradermally in error with no reported adverse event; Initial information received on 25-Jul-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a patient of unknown age and demographics who was not prescribed IPV (VERO) [IPOL] but was prescribed tb skin test and received IPOL in error with no reported adverse event and IPOL was administered intradermally in error with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (VERO) Suspension for injection (strength, lot number and expiry: not reported) via intradermal route in unknown administration site as prophylactic vaccination (immunization); but the patient was not prescribed IPOL but was prescribed tb skin test and received IPOL which was administered intradermally in error with no reported adverse event (wrong product administered) (incorrect route of product administration) (latency: same day) following the administration of IPV (VERO). Information on the batch number was requested.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events wrong product administered and incorrect route of product administration.  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 guidelines. 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.
Generalized itching rash 4 days post vaccination, requiring benadryl aroud the click every 6 hours
After the vaccine, the next day, I was very fatigued and was that way for a couple of days. The following week, I developed a rash that was more like hives on my right leg, inner thigh, over the whole thigh and it remained for about 30 days.
severe chest pains body fatigue little cough rash on shoulders (all thing sI had when I had COVID in April) chills
Arthritis with synovitis starting 3 days after vaccine. Waxing and waning but persists 6 months after incident.
Muscle pain from the injection occurred and lasted approximately 4 days.  In addition, about 24 hours after receiving the vaccine, I began having uncontrolled tremors that lasted about 12 hours.  I also had a fever and fatigue which lasted about 3 days.
Patient developed allergic eczema after 1st dose of DTaP. Doctor suggested that it might have been co-incidental. After subsequent immunization at 4 mos. he woke up the next morning covered head to toe w/ eczema. He also became allergic to more foods than he could eat including: eggs, dairy, peanuts, nuts, potatoes, rice, all legumes, corn, strawberries, all citrus etc. Some effects linger even now 10 years later despite no further immunization.
Fever 102; Bone pain; Chills; Headache; Exhausted.
No further adverse events; Caller is Medical Assistant reporting administered dose of expired MMR II.; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 08-JUN-2022, the patient was vaccinated with an expired vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot # T016352, expiration date 12-MAY-2022 (strength, dose number, route of administration and anatomical location were not provided) for prophylaxis at his vaccination appointment (expired product administered). The patient's father was informed of the event and the recommendations from the manufacturer and physician which was that even though it was expired, there was evidence to support potency of dose as long as stored properly. The patient's father was informed he could get repeat vaccine if desired which they declined. The patient experienced no reaction to the expired vaccine (no adverse event). There was no history of prior temperature excursions on vaccine measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (rHA) (M-M-R II) as no temperature excursion occurred as a result of reading from a Digital Data Logger. It was single use vaccine/vaccine-device. The operator of vaccine/vaccine-device was healthcare professional that was trained. It was unknown if vaccine/vaccine-device was available for return/evaluation. The vaccine was stored in vaccine fridge in clinic. The vaccine/vaccine-device was used according to the instruction leaflet.
Pt experienced tingling of extremities, fever within 2 hrs after vaccine. Fever to 103.5 continued into next day with epistaxis x1 & blood tinged phlegm weakness, some dizziness.
Fluzone given on left deltoid immediately after administration lump formed. patient complains of no itchiness. Lump size 4cm Appointment made for monitoring
1st shot ,headache  , severe soreness at injection site,  2nd shot on 9/15/21  headache immediately , 9/16/21  chest pain ,fever, weakness. anxiety ,unable to sleep for several days. 9/20/21 severe headaches daily ,9/30/21 developed rash and hives all over body,  still having headaches hot flashes.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 1/3/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Had two headaches, front and back; Stomach ache; Loose stools; Hurt all over; Eyes would not stay open, very very tired; Very scary; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Sep2021 at 00:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety and high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paracetamol (TYLENOL) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and experienced drug allergy. On 15Sep2021 at 00:00, the patient felt that the reactions were a lot worse than they should be. On the same day, the patient had two headaches front and back, stomach ache, loose stools, hurt all over, her eyes would not stay open, and was very very tired. She almost went to the emergency room (ER). She would not take the second one. She was very scary. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events had two headaches, front and back, stomach ache, loose stools, hurt all over, eyes would not stay open, very very tired and very scary were resolving at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Elevated ALT Levels; Pregnancy; Initial Report Received on 10-May-2023  A pregnant female patient (age, race, and ethnicity not provided), spontaneously reported to the HEPLISAV-B pregnancy registry that she received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while 30-weeks pregnant and developed elevated ALT levels.  No relevant medical history or concomitant medications were reported.   The last menstrual period date, estimated date of delivery, pregnancy history, and pregnancy risk factors were not reported.  On an unspecified date, when the patient was 30-weeks pregnant, she received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site not reported) from her health care provider (HCP). The patient stated that the HCP did not read the package insert, which advised that this vaccine was not recommended in pregnancy. At the time of reporting, the patient was 35-weeks pregnant, and her ALT levels were elevated.  The patient was offered the option to enroll in the pregnancy registry, which she declined.   No contact information or additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Reports that since he received his 2nd Moderna, he started with "flutters" approximately 2 weeks after vaccinated. He still gets these intermittently. Also c/o weakness that has not resolved.
Extreme pain at instant of injection at site on upper left shoulder. Pain down to fingers for about two days. Decreased to upper arm for days after. Still pain in upper arm 18 days later. Slight fever 2-3 days 9-3 - 9-5. Used hot water and Naprosen for pain. Still aching and tingling in hand/fingers as of 9-27-13.
Client reported feeling dizzy after vaccination. On assessment client appeared  slightly flushed. Client responded appropriately to all questions. Client's blood pressure was 110/56.  Client was given water and a lollipop and monitored. Client's color improved and Client indicated that she was feeling "much better" before client left.
4th & 5thFEB pt ran t101 ax & c/o achy legs; 5FEB 8PM vomited & w/in 15 mins began to convuls; pt recovered w/in a few minutes; taken to hosp; t102.7 R given enema to bring temp; pt had swollen glands & poss ear infect;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JUN-2013, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries (Vaccination failure, Herpes zoster) after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering (Emotional distress) and required extensive medical care and treatment. On 27-SEP-2016 and 17-NOV-2016, the patient was treated by a healthcare providers for shingles and postherpetic neuralgia. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
After getting the vaccine, I had body aches and experienced fatigue. It got worse the following the days. I also had experienced some nausea.
fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heartbeat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat). At the time of the report, HEART RATE INCREASED (fast heartbeat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
shortness of breath after Pfizer booster shot #3  had history of prior reaction to a flu shot many years ago  no wheezing  no stridor  VS stable   Given 25 mg po Benadryl referred to ED for observation as has no one here to do continued observation for next 30 min. Per ED doctor's note:  she feels that her voice is a bit hoarse and her throat feels dry.  She has no chest pain, no rash or diaphoresis.  No evidence of angioedema.   She has no stomach upset.  She reports that she has gotten an EpiPen before, he has not used it at home.  She has been observed in the ED for allergic reactions in the past however she is not ever been admitted. She had a worse response with a flu shot and was given benadryl and observation in the past.
Nausea; Vomited; This is a spontaneous report received from a contactable consumer or other non hcp. A 86-years-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine,Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 10Feb2021 08:56,at the age of 86-years old, as Dose 1,single for covid-19 immunization.Medical history included diabetes mellitus from an unknown date and unknown if ongoing.Additional Information for Other Conditions: Caller says she has been diabetic for 8 years.There were no concomitant medications.The patient experienced nausea and vomited on 10Feb2021.Caller took her 1st dose of Pfizer covid 19 vaccine on 08:56 am and vomited on noon.The patient stated that her vaccine card is handwritten and the NDC/EXP are written on there. She stated that she has done no treatment for the nausea or vomiting, she gets nauseated real easy and her husband says it is probably one of those things.The outcome of the event nausea was unknown while the vomiting outcome was recovered.
Next day morning after vaccine first shot when waking up I felt sharp pain in my left shoulder when tilting my head back left. I thought it was just a muscle pain after sleeping in uncomfortable head position. But pain remain persistent for prolonged amount of time. I am feeling it permanently all the time, can't sleep at night, it disturbs my ability to work.