chrisvoncsefalvay/vaers-outcomes huggingface dataset:
almost immed p/receiving vax pt began crying-mom reported that pt cried excessively & unconsolably for the next 36 hrs;
Brother told doctor at clinic patient was feeling dizzy & lightheaded. Doctor assisted patient from chair to ground and layed her on floor. Cool compress was applied to forehead. No loss of consciousness and pulse maintained throughout conversation. No history of syncope in the past but brother passed out in eye doctor in the past. After few minutes patient felt better was able to sit up on the floor and take some fluids.  after feeling better doctor assisted to walk to car.
This case was reported by a nurse via call center representative and described the occurrence of spleen disorder in a 57-year-old female patient who received BEXSERO for prophylaxis. On 22nd February 2019, the patient received the 1st dose of BEXSERO. On 22nd February 2019, unknown after receiving BEXSERO, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced spleen disorder. On an unknown date, the outcome of the spleen disorder and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the spleen disorder to be related to BEXSERO. Additional details were reported as follows: A 57 year old patient received BEXSERO, which led to inappropriate age at vaccine administration. On an unknown day after vaccination, the patient had splenectomy. No symptoms were reported. The nurse did not know the lot number or expiry date.
Pt recvd vax & exp bad burning & stinging; 7NOV92 Am pt exp bumped up, red itching & swollen inject site, had a moderate migraine, upset stomach (nausea w/o diarrhea or vomiting) & dec sensation of the thumb on 1 hand;
I had chills, still do. I can't get warm.  I stayed covered with clothes and a blanket all day Saturday and Sunday.
two patients received expired ACT-HIB with no reported adverse event; Initial information received on 23-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender two patients who received expired HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Aug-2023, the two patients received an expired dose of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection (lot UJ796AA, expiry date- 12-AUG-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency- same day). Caller would like to know how to proceed?  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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.
Shingles. I started having symptoms 8 days after vaccine. Never had shingles or any other skin rash, I am relatively heathy individual.
pt resides in SNF, and had a positive COVID test on 7/18/22; moved to isolation unit; pt passed away 6 days later in the facility
leg and arms tingling, sharp pains, and ache; shortness of breath; persists
Presented to ED on 8/23/21 with weakness and struggling to get around the house.  Not short of breath and afebrile.  Did receive his COVID vaccine with Johnson and Johnson in May 2021.  He was found to have COVID positive.  He is not hypoxic at this time.  He is just weak and debilitated.  He is agreeable to hospitalization at this time.Patient XR chest and lab work was unremarkable. Patient did not require any respiratory support and vitals were stable. Patient reported feeling better.  Patient was advised to qurantine at home and monitor his symptoms and seek medical care with any changes.   Patient is medically stable to be discharge Home on 8/24/2021
Information has been received from a physician concerning a female who was vaccinated with ZOSTER vaccine. Subsequently the patient developed shingles. The patient sought medical attention with office visit. Additional information has been requested.
(L) upper arm redness & swelling extending onto shoulder blade & down across elbow positive tense positive hot nontender negative itch positive redness.
Started the morning after receiving the vacciine:  Fever, sweats Severe Left Shoulder ache, decrease movement, muscle spasm Pain about the same even after taking pain medication (NSAIDS,  muscle relaxant, heat/cold application)  Pain has continued with no resolution- patient went to see their PCP on 2/9/2021  2/10/2021-  He is back to work, much better ROM to the left arm
After the second dose of the Moderna vaccine for COVID 19, approximately 14 hours after at 5am, I experienced the "normal" signs and symptoms to start. I had fever, aches, chills, fatigue. However, when I walked to my kitchen, I became extremely dizzy, started seeing black spots, and my ears were ringing extremely loud. I thought I was going to pass out. A heat wave came over me, and I had an overwhelming feeling that I was going to throw up. I stripped my clothes off in a hurry to try to cool down and my vision became black. I laid on the kitchen floor for a few minutes and tried to go back to bed. I fell into the bed and began shaking and shivering. My husband was scared. By this time, my vision had returned. The ringing in my ears had reduced but was still present. I slept for over 15 hours and was extremely dizzy any time I got up to get water or use the restroom. By 4pm, I felt slightly better but for a full four days, I did not feel well enough to do anything. Since taking the vaccine, my periods have been different and I lose SO much hair.
A non-serious spontaneous report of left arm pain and left arm feeling heavy and weak has been received from a physician concerning a 25-year-old female, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received H1N1, Intranasal on 16-Dec-2009 for an unknown indication. On 16-Dec-2009, shortly after the vaccine was administered the patient experienced left arm pain with arm feeling heavy and weak. Upon physical exam by the physician, arm was determined not to be weak. The outcome of left arm feeling heavy and weak was resolved whereas left arm pain was unknown.
Case number PHEH2014US022105 is an initial spontaneous report received from a consumer (patient's wife) on 03 Nov 2014. This report refers to a 33 year old male patient. His past medical history and concomitant medications were not reported. On 22 Oct 2014, he was vaccinated with FLUVIRIN (batch number: 1412601) intramuscularly. The patient developed muscle aches, pains, fever and inability to open pill bottles or cut a steak since the vaccination. The patient was immunocompromised and would visit a neurologist. The outcome of the events was not reported. The seriousness of the events was not reported but events were upgraded based on the information available in the source documents. The causality of the events was not reported.
Nose bleed started day after vaccination along with nausea which makes it hard to eat. Had flu like symptoms day of vaccination with head ache and body aches persisting.
Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (658208/0886U) live ZOSTAVAX on 10-OCT-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for live ZOSTAVAX. Additional information is not expected.
Fainting spells started in January 2009. They occurred multiple times per day and continued for over 2 months. She also experienced nausea, dizziness and was lightheaded. She also suffered from fatigue, weakness, stomach aches and muscle and joint pain. She was unable to attend school for an extended period of time.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 8th May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The reporter consented to follow up. No further details were provided. For tolerance after 2nd dose of SHINGRIX, refer case US2018219535.
Initial unsolicited report was received from a certified medical assistant on 23 February 2015. This case is one of a cluster of "almost 10 patients" received from the same reporter (with 8 patients identified). The other patients are captured in cases 2014SA157362, 2015SA023263, 2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and 2015SA023928. An 83 year-old male patient had received on 26 September 2014 an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with expiration date of 12 May 2015) and "shortly after vaccination" was diagnosed with pneumonia; the patient died on 17 December 2014, approximately 3 months after vaccination. The patient had a chest x-ray on which pneumonia was noted; CBC was obtained, but results were not reported. Illness at the time of vaccination was none. Concomitant medications and pre-existing conditions were reported as "NA". No further information was provided. Outcome was fatal. According to the reporter, the report was reviewed and they had no additional information to report at the time. Documents held by sender: none.
the patient received a dose of PEDVAX HIB following a temperature excursion; No other adverse effects were reported in the patient; This spontaneous report as received from a medical assistant referring to a patient of unknown age. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (lot # T000886, expiration date: 29-MAY-2022, route was not reported) for prophylaxis. The vaccine was exposed to temperature above 47 Fahrenheit degree (also reported as 8.8 degree Celsius) for 31 minutes (product storage error). No previous temperature excursion was reported. Data logger was involved. No other adverse effects were reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA001399: US-009507513-2007USA001231: US-009507513-2007USA001265:
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Administer expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided. Expired Moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last 20 Oct 2021 to 29 Nov 2021. The Lot Number of vaccine are as follows, 006C21A (10-10-2021), 026B21A (09-17-2021), 031B21A (9-22-2021). The vaccine was stored in freezer, take out one to two vials and place in fridge each day as needed.
Stomach ache; Dizzy; Feels super sick; Headache; feeling like he has to vomit; Tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache) and NAUSEA (feeling like he has to vomit) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache), DIZZINESS (Dizzy), MALAISE (Feels super sick), HEADACHE (Headache), NAUSEA (feeling like he has to vomit) and FATIGUE (Tired) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: followup information received on 24-JUN-2021 contains no significant information. TCR form attached patient did not have any symptoms after the second shot of vaccine; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
kidney failure; They diagnosed and treated me for dozens of blood clots in my left leg and abdomen which they removed; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An elderly patient received BNT162b2 (PFIZER-BIONTECH COVID- 19 VACCINE), on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (on 05Feb2021 I got my Pfizer-BioNTech COVID- 19 injection (Dose 1)), administration date: 05Feb2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "They diagnosed and treated me for dozens of blood clots in my left leg and abdomen which they removed"; RENAL FAILURE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "kidney failure". The patient was hospitalized for renal failure, thrombosis (start date: 29Jul2021). Therapeutic measures were taken as a result of renal failure, thrombosis. Additional information: So, like a good soldier on 05Feb2021 the patient got Pfizer-BioNTech COVID- 19 injection then followed up with a booster on 26Feb2021. On 29Jul2021, the patient was taken by ambulance to (Hospital name withheld) arriving in total kidney failure. They diagnosed and treated the patient for dozens of blood clots in left leg and abdomen which was removed. The patient was in ICU for 4 days. The patient was now on Eliquis for the rest of the patient's life. The patient was asking for assistance in paying for this drug for the rest of the patient's life, the patient was 77.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
One day post vax, this pt experienced a fever and nausea with painful respirations and urination. He presented to a physician on 04/08 with symptoms. It was reported that the pt is feeling much better. The physician expressed concern with the vax lot number. The pt's physician reported in follow-up that he recovered from symptoms. No further information is available.
pt was about to leave building p/having PE-started c/o chest pain, SOB, nose became congested & started w/cough;10AM DPH given; 1055AM DPH;
Disequilibrium one week after vaccine- dizziness upon waking throughout the day until bedtime; Day 2 dizziness continues with headache in the left temple area
5 days post vaccine came to the hospital with cholelithiasis and underwent a lap cholecystectomy. She was admitted with elevated LFTs and continued to have elevated liver enzymes. She is following up with GI for possible ERCP and has had to stay in the hospital due to this.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-AUG-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician at a community health center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Actual first vaccine was Moderna on 1/13/2021 Lot 025L2014
15 hours after immunization patient reported swelling of tongue. Gums and tongue felt raw. Swelling resolved ~36 hours after onset
could barely move her arm; could barely stand and walk; feels like she has the flu; throat was irritated; nose was stuffed; feeling freezing cold; Body aches; fever (99.8-101.4F); Fatigue; Arm was swollen; A spontaneous report  was received from a reporter concerning a 54-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  The patient's medical history, as provided by the reporter, included she is a diabetic.Concomitant medications were not reported.  The patient received their first of two planned dose of mRNA-1273 on 19jan2021.On 19jan2021 around 4:00pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.     The next day after receiving mRNA-1273, the patient experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.    Treatment for the events included Tylenol and ibuprofen.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events arm  was swollen, could barely move her arm, could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  were considered unknoown at the time of report.    The reporter did not provide an assessment for the events, experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.
Severe headache, fever, eye redness and swelling of injection site approximately 6 inches in length.
gave Spikevax to pt on 10/9/23 at around 9:45am. Pt said reaction started about 4 hours later around 2pm with fever of 101F, chills, and rash on both arms and body trunk. Today 10/10/23 she called pharmacy at 4:55pm to informed pharmacy of reaction. She said the rash is now only on her right arm and trunk. She took a benadryl last the night on 10/9/23 for the itch to help her go to sleep.
She got Albuterol & ipratropium bromide nebs back to back.  Her FEV. improved from 67% to 85% 550mg & 27% improvement  She was discharged with instructions to continue Alb & ipratropium bromide nebs scheduled
Arm hurts; Fever of 101.5 to 101.6; Muscle pain; Really bad headache; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 17-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache). On 17-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm hurts), PYREXIA (Fever of 101.5 to 101.6), MYALGIA (Muscle pain) and HEADACHE (Really bad headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: increased (High) Fever between 101.5 to 101.6 degrees.         No concomitant medications were reported. No treatment information was reported.  It was reported that patient received the first dose of mRNA-1273 on or around 17 Jan 2021.
Left arm became inflamed with blistering.  Inflammation continued spreading throughout the day. Pain and aching accompanied redness.
Left arm with 4" diameter red area, swollen, fever of 101F and chills X 2 days. Treated with Tylenol and rest.