chrisvoncsefalvay/vaers-outcomes huggingface dataset:
THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced the janssen covid 19 vaccine was refrozen and administered to subject, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220538238, 20220537444, 20220537548 and 20220539045.
Fever, weakness, nausea, muscle aches, disoriented, clear change in mental clarity. This went on from 5am-2pm the following day. Same symptoms after receiving FluHD vaccine last year.
11:50 am Moderna administered 11:53 and @ 30 seconds  am it was noted that patient had  multiple small red dots all over her arms and hands. No apparent respiratory distress or difficulty, no nausea, no dizziness. Patient stated they felt " normal" other than the spots. The RN who administered the vaccine did not recall noting the red dots on the patient prior to vaccine administration. At 11:55 am out of caution, the patient was transferred via wheelchair with two registered nurse escorts' to the facility emergency room. Clinical assessment did not indicate the need for administration of injectable epinephrine nor Benadryl ( but these were sent with escorting RN's).
FLUZONE QIV NP PFS reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.   This case is linked to cases 2023SA057309 and 2023SA057733.   This case involves Adult patient of an unknown age and gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event.   It is unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.   On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (poor quality product administered,latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It is unknown if the patient experienced any additional symptoms/events   It is unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   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.   This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.
Has knot at site of DTaP R deltoid red and raised size of 1/2 dollar.
Red rash from shoulders to knees. Rash is not itchy. No fever, nausea or headache.
Allergic reaction that had a slow onset, began with tingling in lips, hands and toes. Felt like small electric shocks through arms and legs. By 7am next morning extremities where white and cold, face and neck were swollen and difficulty breathing. Benadryl 25mg was taken, and again at 1100 on Aug 25, symptoms were relieved and returned in evening. Benadryl continued. On Aug 26, went to Urgent care as symptoms not relieved by Benadryl. Received Decadron . Symptoms of flu like symptoms and arm pain were also noted. Continued use of Benadryl. Symptoms still present at time of report.
Approximately 13 hours after the injection, I started getting severe chills and uncontrollable, violent shaking with great bodily tension. It lasted most all night and into the morning.  The shaking has gone, but it left a slight headache and significant fatigue to the point of trouble getting out of bed.  The fatigue is somewhat better, but it has left a mental fog... through mid day as I write this I have taken Tylenol, which has helped some
Diarrhea, h/a, weakness, sleeplessness, tired, skin blisters;
Onset of autoimmune disease Dermatomyositis with Dysphasia.   Patient has had a total of 4 Pfizer shots {2 original vaccinations, 2 boosters}, with worsening symptoms over time. Discovered this week that there have been new studies showing some individuals have onset of autoimmune disease after vaccinations. Compared vaccination dates with worsening symptoms, and there appears to be a correlation.
Fever of 102.7 degrees Fahrenheit on 10/06/2012; redness, swelling and heat at injection site started on 10/07/2012.
Left arm - large local reaction.  7x6cm area of erythema and induration.  Possibly Cellulitis.  Treated with Keflex for 7 days, Benadryl, and cool compresses.
Sore left arm when lifting or using, hot and cold (chills) dur the night of 9/27 and early morning of 9/28.  Woke up with headache, sore body, extremely tire, slept off and on throughout the day waking up with more chills, no appetite.  9'29 some what better but still tire, no apatite, early evening still had light chills.  Good 9'30, 10/1 woke up with unexplained rash on both ankles, and some welling in left ankle. I have no idea if the booster could cause a rash, but did not do anything  that should have caused a rash or do I have rashes normally. I have not seen or called doctor.
Bladder spasms; Pain; Peeing blood; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (Peeing blood), BLADDER PAIN (Bladder spasms) and PAIN (Pain) 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HAEMATURIA (Peeing blood). On an unknown date, the patient experienced BLADDER PAIN (Bladder spasms) and PAIN (Pain). The patient was treated with PHENAZOPYRIDINE for Bladder spasm and Pain, at an unspecified dose and frequency and NITROFURANTOIN (NITROFURANTOIN MONO/MAC) at an unspecified dose and frequency. At the time of the report, HAEMATURIA (Peeing blood), BLADDER PAIN (Bladder spasms) and PAIN (Pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       N concomitant medications reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Day after vaccine developed redness, pain, swelling, heat at site. Seen in office 2/20/19 and prescribed CLARITIN, BENADRYL and prednisone.
Oonset of rash over anterior and posterior trunk; associated with itching, fever prior to rash flare,  tightness in chest without SOB prior to flare of rash .
Fever, can't remember, remember what happen, came home went to bed and was so sick the next day. Ache, pains and weird feeling in head. Couldn't swallow and went hospital -ER .5/28/2021. Went home and fever and sore throat. Went to doctor on 5/30/2021 - pneumonia. Weirdest cold I ever had in my life. Put on antibiotic. Urgent care - 8/31/2021 - pain in stomach and back and got worst - gall bladder attack/ small bowel obstruction.
Patient received Updated Pfizer Bivalent booster on 10/8/22 at local pharmacy. Drug Store also administered the bivalent booster on 10/27/22
Intussusception diagnosed on 11/2/08 around 4-5 p.m. Symptoms of emesis, colicky ab pain began 10/29/08 in the afternoon. 12/24/08-records received for DOS 11/2-11/3/08-DC DX: Intussusception of small bowel into the cecum. History of crampy abdominal pain for several days intermittent with some blood tinged stools. Reduction of small bowel intussusception with air contrast enema and exploratory laparotomy open appendectomy. In operating room it was found that the intussusception was completely reduced.
Chills, severe body aches, sinus headache, fatigue, nausea, and joint pain for 12 hours. Fever over 102 degrees Fahrenheit, dizziness, and headache for 24 hours.
Pt recv vax on 11/10/97; in 12/97 pt exp cardiomyopathy
Breakthrough case admission after 2 vaccines Pfizer 4/30/21 Lot# Ew0172;  Pfizer 6/1/21 Lot# Ew0186
This spontaneous report was received from a registered nurse and refers to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported. Since 28-JUL-2020, improperly stored VARIVAX including lot number T002843, expiration date 23-JAN-2022; and lot number S032357, expiration date 14-OCT-2021, have been experienced an intermittent temperature excursion of -14 degree Celsius (°C) to -10 °C (maximum average temperature was -9.5 °C) for a period of 38 hours and 30 minutes, but it was not reported before. Then, on 31-JUL-2020, the patient was vaccinated with an improperly stored dose of VARIVAX 0.5 milliliter (dosage regimen and route of administration were not provided), lot number S032357; expiration date 14-OCT-2021, as prophylaxis. It was reported that the reported lot # did not have a previous temperature excursion. The call was because a digital data logger.
Pt. c/o "feeling funny" and of palpitations after 2nd dose of Covid vaccine. Pt has a history of A. Fib and HTN. Vital signs taken, EKG completed and reviewed by provider. Provider noted palpitations likely due to anxiety related to vaccine. Pt. discharged to home and given ER precautions.
Blister type rash on thigh area (left lower) fevers, very irritable, not sleeping.
Exacerbation of chronic fatigue, "burning" eyes, "brain fog", chills, metallic taste in mouth, mouth sores, decreased appetite.
radiating pain in chest; radiating pain in left arm; radiating pain in neck; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced neck pain. On an unknown date, the patient experienced chest pain and pain in arm. The patient was treated with ibuprofen. On an unknown date, the outcome of the neck pain, chest pain and pain in arm were unknown.   It was unknown if the reporter considered the neck pain, chest pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received vaccine 72 hrs from the date of reporting. The patient expereinvced pain raidiating around neck, chest, left a arm minor relief with 400mg Ibuprofen q6, but seems to be getting a little worse.
Vaccine administered 7/17/02. Nurse informed of IgA deficiency disorder at the interview prior to receiving vaccine per mom's statement. Verbal permission given by unknown source. 7/27 pt ran temp and diarrhea appeared. Pt still has infection (respiratory and with eyes) and chicken pox and is not sleeping. Treated in ER and by physician according to mom's statement.  Follow up on 11/05/2003: "Vaccine recipient is unknown about recovering from adverse event."
Second dose is rescheduled 47 days out from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is rescheduled 47 days out from the first dose) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 027B21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and VITAMIN D3 for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is rescheduled 47 days out from the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose is rescheduled 47 days out from the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-060640 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Follow up received on 25-JUN-2021 - Second dose and contact details updated .; Sender's Comments: Very limited information regarding this event has been provided at this time. US-MODERNATX, INC.-MOD-2021-060640:Same reporter (MOD21-064572)
None. Report filed b/c patient inadvertently given both PROQUAD and VARIVAX (double varicella vaccine). Pt did not develop vaccine induced dz.
COVID-19; COVID-19; This is a solicited report from a contactable consumer (patient) via the Regulatory Authority based on information received by Pfizer from Regulatory Authority (manufacturer control number: 21K-163-4035772-00).  A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 10Mar2021 (Batch/Lot number was not reported), and dose 1 on 02Feb2021 (Batch/Lot number was not reported): both intramuscular  as single dose (at the age of 66-years-old) for COVID-19 immunization. Medical history included Moderate to severe rheumatoid arthritis and Moderate to severe chronic plaque psoriasis. The patient's concomitant medications were not reported. The patient experienced COVID-19 on Aug2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on Aug2021. The outcome of the events was recovering. The events were considered as serious (medically significant).  Solicited report from the Regulatory Authority by a consumer of a 66-year-old female with event of COVID-19. There was no reported medical history (as reported). In Aug2021, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 02Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number Unknown. On 10Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer, lot number Unknown.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event of COVID-19 was possible.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Vaccination failure and COVID-19 and the suspect drug bnt162b2.
HIS ARM WAS REALLY SORE FOR THE REST OF THE DAY AND INTO THAT NIGHT. BY THE NEXT MORNING THE SORENESS WAS MORE LIKE THE NORMAL SORENESS FROM GETTING THE SHOT. BY THE NEXT DAY IT WAS FINE, NO SORENESS REMAINED. IBUPROFEN DID NOT HELP WITH THE PAIN.
It was reported that a 46 year old female pt received a Fluzone SV '00-'01 vaccination on 9/22/00 at 08:00 as well as having blood drawn in the same arm. The pt contacted the Center to say that her hand was swelling and the injection site was sore. The pt was referred to her physician. Reportedly, the pt recovered from this experience. Received correspondence on 2/1/01 stating "nothing more to add".
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with unspecified doses of improperly stored ROTATEQ (lot # M004508, expiration date 29-JUN-2017, route not reported). No adverse effects were reported. Additional information has been requested.
Initial report received on 02 October 2009 from a health professional. A 9 year old male patient, with a history of asthma and unspecified allergies, received a left deltoid intramuscular injection of FLUZONE (lot number U3203AA) on 30 September 2009. The patient had no concomitant medications, no illness at the time of vaccination and no other vaccinations had been received within the four previous weeks. The following day, 01 October 2009, the patient had swelling at the injection site. Two days-post-vaccination (02 October 2009) the swelling was from the shoulder to the forearm, it was warm to touch, and there were blisters on the shoulder. The patient had no fever and was otherwise in good general health. Corrective treatment was BENADRYL, ADVIL, and antibiotics. At the time of the report, the patient had not recovered. Follow-up information was received from the health care professional on 02 November 2009. The patient had previously received six doses of FLUZONE with no associated symptoms (22 September 2008, 14 November 2007, 30 October 2006, 16 November 2005, 21 October 2004, and 01 December 2003). Treatment for the event included OMNICEF 250 bid for three days, BENADRYL 5 mL tid for five days, and ADVIL 200 tid for five days. The swelling persisted for three days, and the patient was considered to be symptomatic by 05 October 2009. The final diagnosis was "hypersensitivity". The reporter had no additional information to provide.
Severe lump, redness and itching at injection site. Hot to the touch and extremely sore. No other side effects. Tylenol for arm pain.
she still got covid twice after get the second shot; she still got covid twice after get the second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2011, stop date: 2011, notes: Caller claims to have had covid back in 2011, and reports that she got covid again just last year. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "she still got covid twice after get the second shot".  Clinical information: The reporter reported that she still got covid twice after get the second shot. The reporter claimed to have had covid back in 2011, and reports that she got covid again just last year.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300029596 Same patient and drug, same event in different time;
Body aches starting 5 hrs after injection lasting 16 hrs Headache starting 5 hrs after injection lasting 20 hrs Fever starting 8 hrs after injection lasting 11 hrs. Fever spiked at 102 and remained there for 6 hrs. Chills starting 6 hrs after injection lasting 15 hrs. Fatigue starting 8 hrs after injection.  I took Tylenol to reduce the fever and to help with muscle aces. I took 2 every 4 hours starting when the fever did 8 hrs after the injection. All symptoms were gone after 24 hrs.
I would describe symptoms as ?mild?, but as this was only the first shot, I thought they were worth reporting.  From 12 hours after my shot to about 48 hours afterwards, I experienced extreme fatigue, irritating rashes on the backs of my hands (which now went away), stomach pain, and a racing heart beat.  All of which are also symptoms of mild covid.  I seem OK 2 days afterwards.
I came home and was prepared to no feel good since the first dosage of the vaccine caused issues and this is the 2nd dosage. I started to feel tired and begin having headaches along with body aches. I took some Tylenol to see if the headache would go away, ended up with the a fever of 104 and managed to break the fever. The body aches went on for three to four days and I had joint pain that worsen with the second dosage of the vaccine. My husband is a Doctor and suggested that I treat the acute symptoms to see if they would go away and the joint pain continues in my knees, ankles, hands plus the fatigue has not subsided. I generally don't fee well and I did not have issues prior to the shot (husband contacted COVID and I may have had some of the symptoms prior to receiving the vaccine.
A non-serious spontaneous report of crying hard and turned blue has been received from a physician concerning a female infant, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Medical history of the patient includes that patient is a blue baby. Concomitant medications have not been reported for this patient. The patient received dose of FLUMIST on an unknown date in Apr-2010 for an unknown indication. On an unknown date in Apr-2010, the patient was crying really hard and turned blue. The pediatrician was not concerned as the patient was a blue baby. The outcome of the events was unknown.
Swelling of upper arm, redness and severe itching. Went to my primary care doctor. She prescribed Cephalexin. I have been taking one 500mg capsule three times a day. I have also been using aloe for the itchiness. The redness is gone. The swelling has gone down significantly. The itchiness is gone. I also had  redness on my right arm, but it was not itchy.
Pt had inconsolable screaming w/high pitched abnormal cry that lasted 2 hrs; Felt very hot, but did not have a thermometer;
dizziness, lightheadedness, anxious, observation done, juice offered, symptoms resolved, pt went home
w/in 2hr p/vax pt began to feel warm & lightheaded;pt stated didn't feel good;afeb;pt stated arm was excruciatingly painful to move from collar bone to fingertips;pt felt warm;pallor;heavy feeling in arm;not self;soreness in arm;
Received Hep A #1 and Varicella #2 1/26/09. Early AM, 1/27/09 parents noted m/p rash forehead. No vesicles, no fever, no redness. Resolved 14 days.