chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was exposed to 70 F got 117 hours and 5 minutes. with no adverse event; Initial information received on 18-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced vaccine was exposed to 70 f got 117 hours and 5 minutes. with no adverse event while receiving vaccine Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria 2/tetanus/5 ac pertussis vaccine (lot number: U7271AA) (unknown strength, dose, route, dosage form and expiration date) via unknown route in unknown administration site.   On an unknown date the patient developed a non-serious event vaccine was exposed to 70 F got 117 hours and 5 minutes. with no adverse event (Product storage error) (unknown latency) following the administration of diphtheria 2/tetanus/5 ac pertussis vaccine.  Action taken: Not applicable.   Corrective treatment: Not provided.  Outcome: Unknown.  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 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.
Sore arm for over a week after vaccine administration. No swelling or redness. No changing in soreness (same constant soreness, not improving or getting worse). Pt has tried ice and already takes NSAIDS consistently for back pain. Nothing makes the soreness go away. Pt contacted MD for advice. MD said it's not unusual for tetanus shots to cause soreness that lasts over a week. Continue ice and Ibuprofen 600 mg TID.
0838 Patient received vaccine Pfizer 3rd dose in right arm. Patient waited observation time for 15 minutes, and at approx. 17 mins past, 0901 patient complained throat was abnormally tight, cough was present, and tongue was slightly tingling  . Denied itchiness, complained that a abnormal feeling of tightness was accompanied the vaccine. At approx 0903 Benadryl 50mg was given PO. RN stat notified, and patient was wheelchaired over to urgent care for further evaluation.
This spontaneous report was received from a pharmacist via a company representative, concerning two adult patients in their 50's of unknown gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, both patients were vaccinated with a dose of ZOSTAVAX vial (dose, frequency and route were not reported) lot # M032638 with an unknown expiration date, for immunization; in combination with Sterile diluent injection (lot # reported as L006550 and the expiration date was not provided). On an unknown date, both patients experienced swelling around injection site and swelling was as big as lemon for both patients. They went to see the pharmacist about swelling and BENADRYL was recommended. On an unspecified date, the patients' swelling went down "within a week or so" after taking BENADRYL and they were reported as recovered from the adverse event. The causality between the adverse event and ZOSTAVAX and the sterile diluent was unknown. Additional information has been requested.
Sudden onset of headache, chills, nausea, vomiting.  Neck pain was noted in the ED.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a noncontactable consumer. A 41-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 41, via an unspecified route of administration, right arm, on Apr 11, 2021, at 14:45, single dose, for COVID-19 immunisation. Medical history included migraine headache. The patient did not have any allergies to medications, food, or other products.  Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medication included Excedrin (acetylsalicylic acid/caffeine/paracetamol) taken for unknown indication from unknown date. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 41, via an unspecified route of administration, right arm, on Mar 21, 2021, at 14:45, single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 12, 2021, at 01:00, patient experienced migraine headaches and was unable to sleep. No therapeutic measures taken as result of adverse events. Since the vaccination, patient has not tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of migraine headaches and unable to sleep was resolving. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium
This is a spontaneous report from a Pfizer-sponsored program. A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 9, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient had a headache that turned into a migraine on Feb 10, 2021. The reporter calling on behalf of his mom. She took the 1st dose, then right after this morning she experienced a headache that turned into a migraine. Caller asked if his mom could take generic Excedrin. The outcome for all events: unknown. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
Red rash (inflammation and itchiness) appeared on day 9 of first vaccine dose. Rash was small, about the size of a silver dollar approximately 5 inches below injection site. Treatment was a topical steroid cream (cortisone) applied a couple times a day for 2 days. Itching stopped after 3 days and redness went away after 5 days. No rash has reappeared since.
lots of sleep; dizziness; short of breath; feeling lots of malaise; fever; headache; lots of chills; lots of tirednessand fatigue; This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (lots of sleep), DIZZINESS (dizziness), DYSPNOEA (short of breath), MALAISE (feeling lots of malaise) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPERSOMNIA (lots of sleep), DIZZINESS (dizziness), DYSPNOEA (short of breath), MALAISE (feeling lots of malaise), PYREXIA (fever), HEADACHE (headache), CHILLS (lots of chills) and FATIGUE (lots of tirednessand fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, HYPERSOMNIA (lots of sleep), DIZZINESS (dizziness), DYSPNOEA (short of breath), MALAISE (feeling lots of malaise), PYREXIA (fever), HEADACHE (headache), CHILLS (lots of chills) and FATIGUE (lots of tirednessand fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    Concomitant medications included inhaler for asthma
Pain; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number Unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that was okay for an hour and then suddenly the patient on an unspecified date experienced pain and felt like stuffy and painful in patient nose and running a little bit.  The patient was treated with BENADRYL. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
About two weeks after the first injection I experienced significant dizziness/motion sickness when I got out of bed.  It felt like I was on a ship in heavy seas.  I don't think I could have driven a car.  I laid down around noon and slept for about 90 minutes.  Upon waking the symptoms had lessened.  I had another occurance (about the same severity as my post-nap symptoms from previous incident) on April 4th.
Received Rotavirus vaccine on Monday morning (am) (June 16th 2008) by Thursday morning my son had not had regular bowel movements, was discomfort during sleeping hours nights prior, Thursday morning my son began to show signs of being lethargic, refusal to eat and what ever he did eat he began to vomit and scream in pain. (reportingly a neighbor called the local police to report a child screaming excessively). My son was taken to our pediatrician for examination Thursday (June 19th, 2008) morning at that point the pediatrician recommended my son be taken to a local hospital for an X-Ray & Ultrasound for what appeared to be "Intussusceptions"; Local Hospital confirmed via. x-ray/ultrasound scans "Intussusceptions" but the facilities were unequipped for this type of pediatric condition and recommended my son be taken to "Hospital" immediately where it was confirmed via. scan the Intussusceptions was positive. A procedure was performed via. an "Enema" technique to reduce the intestine. The procedure worked, my son was hospitalized for observation and released on June 21st, 2008. In less than 24 hrs my son was rushed back to "Medical Center" on June 22nd, 2008 for the same condition reoccurring. All the previous signs began in the early morning of the 22nd of June. A scan was performed confirming the Intussusceptions had occurred for the second time in less than a few days apart from the 1st occurrence. The same "Enema" procedure was performed and my son was hospitalized again from June 22nd - to - June 25th. 7/14/08-records received for DOS 6/19/08-DX:Intussusception. Presented with irritability and intermittent inconsolability. Tenderness right side of abdomen. Day prior non-bloody non-bilious emesis and 2 non-bloody stools.. 7/25/08-records received for DOS 6/22-6/25/08-DX:Intussusception with successful reduction with air enema. C/O abdominal pain decreased oral intake. Seen prior to this admission for intussusception. No fever, diarrhea, vomiting. Abdomen nondistended, non tender.
My mouth, lips and tongue have a strange sensation and feeling, It feels like I had my mouth was numbed by a dentist and I am coming off the effects. I have also had mouth ulcers. Note: my wife has been having the same effects.
Skipped heart beats, light headedness, dizziness, heaviness in chest, intermittent cough, lasting 2-24hours but happens daily.  Began 24 hours after vaccine and continues to this day.
No additional AEs; expired lot of VARIVAX was administered to patient; This spontaneous report was received from a Registered Nurse (RN) regarding a 6-year-old-female patient. Her medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On 18-APR-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter once, lot # U012222 and expiry date: 16-APR-2023 (route of administration was not provided) for prophylaxis. No further information provided, no additional adverse events were reported.
Started with a cough and congestion on 1/23. The cough was the major symptom, did not have fever. Had mild headache, not terrible but that was really it. Called PCP and he prescribed Paxlovid. Started taking Paxlovid on 1/24. I did get Paxlovid rebound about 2-3 days after finishing it, but tested The cough lasted a while, for several weeks.
started having spasms to left arm and back. Also feels dizzy and nauseous. While speaking with advice nurse started having chest and left jaw pain. Member was at work and called emergency response number.
Vaccinee rec'd 1st Engerix-B vax (unspecified date) & experienced a rash that lasted several days. P/2nd Engerix-B vax on 18OCT90 again experienced rash which lasted 7-10 days.
sore arm (pt was given higher dose of 30 mcg/0.3ml Pfizer vaccine)
A little pain; Low grade fever 100.1 f; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (A little pain), PYREXIA (Low grade fever 100.1 f) and HEADACHE (Mild Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 degree Celsius (High) 100.1 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details not provided by the reporter.    This case was linked to MOD-2021-027745 (Patient Link).
Localized red bumps, warm, conflient redness, night tremors, crying in sleep, difficult to console, itchy/scratch B proxal thigh at injection site. Rx topical calage, oral Benadryl OTC- improved
Sinus infection and bronchitis, coughing, congestion, headaches, body aches, fatigue. Length of recovery is over 2wks- longer than normal
Patient is a 56 yr old male with medical history significant for cirrhosis with history of hep B and hep C which he states have both been treated and cleared, chronic back pain on daily opioids, CAD with stents, DM2, and depression/anxiety on daily diazepam. He reports that he had been feeling dizzy all day today, and when he stood up from the toilet, he again became dizzy and fell, landing on his R hip. He also reports that he hit his R forehead, but has no bruising or pain there, no headache. He is unsure why he was dizzy today, but states it may be due to his oxycodone and diazepam, although he takes these every day without dizziness. Due to severe R hip pain, EMS was called and he was brought in to ED for  further evaluation. In the ED, Xrays reveal mildly displaced R femoral neck fracture and L lateral 9th rib fracture without displacement or pneumothorax. He is pancytopenic with WBC 1.7, hgb 11.6, and plt 39. He has a temp of 99.4 and COVID test was positive. He is fully vaccinated and boosted, booster was given in October 2021. He denies SOB, denies cough, denies any COVID symptoms. Recorded O2 saturations noted to be variable from 97% on room air to 89% on 2L per cannula. Dr  has been consulted and hip repair is planned for tomorrow. He has received dilaudid and zofran in the ED, and the hospitalist service is asked for admission.  PT IS INPATIENT AT THIS TIME.
Red rash, heat and tenderness around injection site.  Approx 2 inches long by 1.5 inches wide.  No treatment yet.
Nausea, dizziness and fatigue with this vaccination and she also now recalls having this with the first vaccination on 7/30/04.
Information has been received from a physician concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 30-NOV-2011, was vaccinated IM with the first 0.5 ml dose of GARDASIL (site and lot# not reported). On 02-FEB-2012, the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL (site and lot# not reported). There was no concomitant medication. It was reported that the patient developed an enlarged supraclavicular lymph node with pain on movement after receiving her first dose of GARDASIL. This developed within 24 hours of receiving the vaccine. The physician reported that the patient developed the enlarged supraclavicular lymph node again after receiving her second dose of GARDASIL. The physician stated that it also developed within 24 hours after receiving the second dose of GARDASIL and the enlarged supraclavicular lymph node was also on the same side that the "second" dose of GARDASIL was administered. The physician reported that the enlarged supraclavicular lymph node had gotten smaller and was the size of a "pea". The patient sought medical attention by office visit. The patient did not have any lab diagnostics studies performed and did not receive any treatment for the event. At the time of the report, the patient was recovering. Follow up information was received from a physician reporting that the 14 year old female with no illness at time of vaccination, no pre-existing allergies, birth defects or medical conditions, on 30-NOV-2011 at 16:45 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 1497AA, Exp. Date: 26-JUN-2014). On 02-FEB-2012 at 15:45, the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL (lot number 1566AA, in validation) and on 07-JUN-2012 at 15:30 was vaccinated intramuscularly with the third dose of GARDASIL (lot number 672834/0131AE, Exp. Date not reported). The three doses were administered at private doctor's office/hospital with private funds. The physician stated that in December 2011 (previously reported as 01-DEC-2011) the patient developed enlarged supraclavicular (two nodes) shortly after received vaccine #1. Nodes reappeared on 02-FEB-2012 (previously reported as 03-FEB-2012) and the patient developed supraclavicular nodes when the patient received vaccine #2, and again on 09-JUN-2012, two days after vaccine #3 was administered, the patient developed supraclavicular nodes. Nodes resolved spontaneously on 23-JUN-2012. Additional information is not expected.
DIZZINESS; STOMACH BLOATING; EXTREME MUSCLE PAIN IN HIS NECK AND BACK; FEVER; NAUSEA; STOMACH PAIN; DIARRHEA; This spontaneous case (PVX2019-750) was received from a consumer on 28-Mar-2019. It describes a 42-year-old adult male consumer (height: 72 inches/ 182 cm and weight: 210 pounds/ 95 kg) who experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea, while receiving oral Vivotif (one capsule every other day) for typhoid prophylaxis.  Case report: The consumer took Vivotif doses on 18-Mar-2019, 20-Mar-2019, 22-Mar-2019, and 24-Mar-2019, respectively. On 25-Mar-2019, he had a fever (about 100 degree Fahrenheit), nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea for 4 days. He did not receive any treatment for nausea, stomach bloating, dizziness, stomach pain, and diarrhea. The muscle pain was mostly in his neck and back, which got worse at the time of this report. He took Tylenol (paracetamol) and oral Advil (ibuprofen) one tablet every 6 hours from 25-Mar-2019 for fever and muscle pain. He also stated that out the events stomach bloating, dizziness, and stomach pain were the worst symptoms.  The consumer had no medical history or allergy. He smoked half pack per day and consumed about four drinks per week.  Concomitant medication at the time of the events included Zyrtec (cetirizine) (once daily for last few months). He was taken regular strength of Tylenol (paracetamol or acetaminophen) and oral Advil (ibuprofen) in every 6 hours on 25-Mar-2019 for fever and muscle pain.  Action taken with Vivotif was not applicable.   The consumer had recovered from the fever on 26-Mar-2019 but did not recover from nausea, stomach bloating, dizziness, stomach pain, diarrhea, and extreme muscle pain in his neck and back.  Company's Comment: In this case, it was reported that a 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 42-year-old adult male consumer experienced fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever, nausea, stomach bloating, dizziness, extreme muscle pain in his neck and back, stomach pain, and diarrhea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Pain in upper armpit area on same side as injection site, left side. Onset about 8 hours after injection. Application of warm towel for relief. Still persisting, but subsiding 48 hours after injection.
approx 15-20 mins p/shot c/o SOB, lungs clear, rash across chest shoulders & around shot site; pt came to acute care area of clinic; EPi & DPH given; Tachycardia & SOB & rash resolved p/tx;
Patient was observed for 30 minutes and she left. She returned a short time later and reported feeling flush and a bit of chest and throat tightness. Stated having many trips to the ER in the past for anaphylaxis, she no reaction to her first dose and says her allergist told her she was safe to receive the second dose. We sent her to the ER following her elevated blood pressure and assessment of her swollen hard/red injection spot.