chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representative referring to a patient of unknown age and gender. The patient's medical history, drugs reaction or allergies, concurrent conditions and concomitant therapies were not reported. On 21-MAR-2016, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB. "10 PK 0.5 mcg/0.5ml SDLLolCap Ped" and lot number L023387 with expiration date of 22-JUN-2017 (route and anatomical location of administration were not reported). The vaccine had two temperature excursions one of 16 hours with a lowest recorded temperature of 49 Fahrenheit (F) (9.444444444 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
During injection of the vaccine, the needle withdrew prematurely and the vaccine leaked out. The solution was visually seen running down the individuals arm and 0.4 ml of the vaccine remained in the syringe.  We were using a vanish point 1.0 ml single use syringe.   This dose was considered wasted and the vaccine was administered with another syringe and needle.
A 20 year old female patient experienced depression while receiving RabAvert therapy. The patient received RabAvert in August 2004 for post exposure prophylaxis. Past medical history and concomitant medications were not provided. In August 2004, the patient was exposed to a bat and began RabAvert prophylaxis. On day three after starting RabAvert the patient complained of depression. She was seen by a physician who stated her examination was within normal limits and she had no other complaints during or after the RabAvert series. The depression had persisted at the time of this report. Follow up received 09/17/04: The patient received RabAvert doses beginning in late August 2004 on days zero, three and seven. The day 14 dose was administered in September 2004. The patient had no significant past medical history and no known history of depression. She was not on any concomitant medications. The patient developed depression after receiving RabAvert and was seen by a psychiatrist for her first visit for counseling one to two days ago. She was treated by the psychiatrist with a medication (unspecified) and the psychiatrist will see the patient again as the depression is not resolved. The patient also developed a low grade fever after the third dose of RabAvert, treated successfully with Tylenol. The fever resolved and she did not develop fever after the fourth dose. The psychiatrist's opinion was that the depression was not related to the vaccine. Follow up received 09/23/04: The patient received her fifth dose of RabAvert on 09/21/04. All immunizations were administered from the same lot and the lot number was provided.
The patient fainted a few minutes after receiving the vaccine. She came to shortly thereafter and checked out thoroughly by paramedics. All vitals were normal and she was picked up by another party.
This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 01-DEC-2015, the patient was vaccinated with the first dose of LIQUID PEDVAXHIB injection (strength, dose, lot number and expiration date were not provided) for prophylaxis. On 16-FEB-2016 and 03-NOV-2016, the patient was vaccinated with the second and third dose of LIQUID PEDVAXHIB injection (strength, dose, lot number and expiration date were not provided) for prophylaxis, respectively. On 24-FEB-2017, the patient received a fourth dose of LIQUID PEDVAXHIB intramuscular injection (strength and dose were not reported) (lot number: M045207; expiration date: 30-JUN-2019) for prophylaxis. No adverse effects were reported. Additional information is not expected as the reporter refused additional contact.
No symptoms with first dose, but 10-15 minutes after receiving her second dose of Pfizer vaccine, her throat began to swell and she felt dizzy. EMS came to take her vitals and gave her oral Benadryl. The patient felt much better after 15 minutes. She said it was a similar reaction to when she is exposed to eggs or nuts.
Child developed diarrhea 4 hrs p/receiving immun; Occurred x 2 that evening; Continued x3-4/24hrs;
My Immunization technician gave vaccine too high in the arm and he might hit her bone.  She has pain at the injection site for 2-3 weeks then it go away but it come back sometimes.
pt reports dx of poss transverse myelitis; sx include bowel & bladder urgency, frequency, incontinence & progressive numbness from legs to waist;
Developed bilateral ear muted hearing on evening of October 17, progressed to numbness extending from behind left ear up towards left eye and into cheek area, lesser extent on right. Right resolved. Left numbness resolved within short time but hearing remained muted. Woke up next morning and muted hearing was gone, but I was dizzy for a several minutes, as that resolved, I developed tinnitus in my left ear and it has persisted. I have been seen by my PCP shortly after this started, no issues have been identified. I am seeing an EENT in April. I have not had any further dizziness. Right ear has been fine.
FEEL HARD HOT AND RED. SWELL LIKE GOLF BALL. MD SAID IT IS INFECTED.
Pt states that a few hours after receiving the Heplisav B vaccine she developed Hives and a feeling of her "throat closing". Pt states she did not report this to her PCP or to the clinic where she received the vaccine. She treated herself with Benadryl, zyrtec, and hydroxyzine with relief.
day after: all CDC side effects + sore chest + neck pain + sleeping for 16 or more hours 2 days after: all CDC side effects + chest pain + trouble breathing 3 days after: lessening of all CDC side effects to no CDC side effect + trouble breathing through ER prescribed medication (2 inhalers) 4 days - 4 weeks after: intermittent shortness of breath fixed through further prescribed medication (2 inhalers) and steroid given 5+ weeks after: no noticeable side effects
This spontaneous report has been received from a registered nurse, and refers to an 18 week female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 02-NOV-2017, the patient inadvertently received first dose of ROTATEQ orally for prophylaxis lot number M044399 (dose and expiration date were not reported). There was not product quality complain or adverse effect involved.
I am still feeling effects. Tired, fever, head pressure and ear pain. And then today 4/28/21 almost a week later I now have an eye infection.
Vaccine administered on 02/16/05, MMR to right arm, 5x4 cm erythemic area.
DOLOR DE CABEZA ARDOR EN AMBOS OJOS DOLOR EN EL CUERPO INAPETENTE FIEBRE
Headaches like a Migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headaches like a Migraine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
thrombocytopenia/low platelet; Patches on both legs, like little red dots/looks like i'm bleeding under my skin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOCYTOPENIA (medically significant) with onset 05Jan2022, outcome "not recovered", described as "thrombocytopenia/low platelet"; PETECHIAE (non-serious) with onset 05Jan2022, outcome "not recovered", described as "Patches on both legs, like little red dots/looks like i'm bleeding under my skin". The patient underwent the following laboratory tests and procedures: platelet count: (05Jan2022) low. Patient was asking She got her 1st dose (Pfizer covid vaccine) on 21Dec2021 and this morning she had patches on both legs, like little red dots (they were not itchy as per caller) and they were not going away. It looks like she was bleeding under her skin. she think it could be thrombocytopenia/low platelet, She read that it can cause this. She want to know what to, she was scared to get the second dose. Response received included No specific information found on patches or red dots or thrombocytopenia. They explained to caller that if she feels or believes she has thrombocytopenia then she should seek medical attention. Caller stated she would go to ER.  The lot number for bnt162b2 was not provided and will be requested during follow up.
head ache chills fatigue loss of appetite pain at location of injection gradually t spread to overall pain dizzy symptoms are resolving still noticing dizziness by day 2
Pt COVID + on 11/15/2021.  Fully vaccinated.  Admitting dx: altered mental status.  COVID 19, pneumonia, severe sepsis.  Lactic acidosis.  56-year-old gentleman with a past medical history of COPD due to alpha antitrypsin deficiency, asthma, CHF, diabetes, hypertension, CVA, who presented to the hospital with altered mental status.  The patient's 2D echo showed ejection fraction 70%.  EKG, sinus tachycardia.  CT abdomen and pelvis showed concern about colitis.  Lactic acid was elevated.  Admitted to the hospital with concern about sepsis.  Was seen and evaluated by multiple consultants with cardiologist and Critical Care, Vascular team and Surgery.  CTA of the chest showed a pericardial effusion with new compared to the previous study and there is emphysematous change in the lungs.  Treatment:  antibiotics, IV fluids, pressors, The patient was intubated and on November 20, 12:45 terminal wean was done and the patient expired.
Intense hives; burning, itching, red and white raised welts; hives showed up the evening of the day after vaccination and were covering entire body by the morning of the day after that. Went to the ER for treatment was given benadryl and a prescription of prednisone. Hives almost went away for several how's after taking prednisone, but returned and continued for a week and a half.
Information has been received from a nurse referring to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On an unknown date in OCT-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L048237 and expiry date 18-MAY-2017) for prophylaxis (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The GARDASIL 9 experienced multiple temperature excursions. Currently (unknown date) the vaccine temperature excursion was minimum of 1 degree Celsius and maximum of 5 degree Celsius for time frame of 40 hours. The vaccine had previous temperature excursions on 06-SEP-2016 exposed to 1 degree Celsius for 72 hours and on 07-SEP-2016 exposed to 1 degree Celsius for 17 hours. Data logger was not involved. No product quality complaint was involved. Follow-up information has been received from the registered nurse on 13-DEC-2016. She stated there was no adverse event. Additional information is not expected as all follow-up information had been received. Reporter, event and narrative were updated. Sender's Comments:  MERCK 1610USA008843: Mfr number.
red splotch on vaccine arm; also noticed splotches on her head and face; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METOPROLOL, AMLODIPINE and CHLORTHALIDONE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face). At the time of the report, VACCINATION SITE RASH (red splotch on vaccine arm) and RASH MACULAR (also noticed splotches on her head and face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment details were provided.   Reporter did not allow further contact
She reports approx 1.5 inch circular erythematous area to right post upper arm where varicella was given. Area is also sl warm to touch and itchy. NP looked at area and recommended ice and BENADRYL.
BURNING, REDNESS, SWELLING 8 INCHES FROM INJECTION SITE.
Shot given 2:34 pm. Severe site pain (arm) and SOB at 5:30 pm. Spiked fever overnight and had nausea and extreme fatigue.
Information has been received from a registered nurse concerning a 2 month old female who was vaccinated PO with her first dose of Rotateq.  Concomitant vaccinations administered "at the same visit" included a dose of Comvax (OMPC) (MSD), a dose of PREVNAR, and dose of DTaP and a dose of IPV (unspecified).  Other concomitant medication included ZANTAC one week prior to vaccination.  Subsequently the patient developed diarrhea 2 days after the first dose of Rotateq lasting for 4 weeks.  The patient also developed a fever (course and duration not specified).  Medical attention was sought through contacting the physician's office.  The patient was treated with TYLENOL.  The patient's recovery status was unknown.  There was no product quality complaint.  Additional information has been requested.
Approx 10-15 min post-vaccine, pt began to c/o flushing and bilat feet numbness/tingling. NIBP 172/90, HR 90s. No SOB, hypoxia. Benadryl 50 IM given @ 1756. Pt discharged from vaccine clinic to ED. NIBP 157/111, HR 102 @ time of discharge.
nerve damage from past and shot caused more pain; Had all the reactions from shot except nausea; This case was reported by a consumer via media and described the occurrence of exacerbation of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles in the past twice). Concurrent medical conditions included nerve damage (had from past shingles) and pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced exacerbation of pain and nausea. On an unknown date, the outcome of the exacerbation of pain and nausea were unknown.   The reporter considered the exacerbation of pain to be related to Shingles vaccine. The reporter considered the nausea to be unrelated to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she just got the Shingles shot and himself/herself having shingles in the past twice and had nerve damage from past and shot caused more pain. The patient stated that he/she had all the reactions (unspecified) from Shingles shot except nausea. The follow-up would not possible as no contact details were available.
Full body rash, raised red bumps, extremely itchy. They appeared in groups & would come in waves, also, would shift from one part of body to another. Had dizzy/fainting spells. Pt. went to the DR the next day & was told it could be allergy.
This case was reported by a nurse via sales rep and described the occurrence of welts in a 5-year-old female patient who received FLULAVAL QUADRIVALENT. On 23rd October 2017, the patient received FLULAVAL QUADRIVALENT .5 ml. On 24th October 2017, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced welts. On an unknown date, the outcome of the welts was unknown. It was unknown if the reporter considered the welts to be related to FLULAVAL QUADRIVALENT. Additional details were reports as follows: The case was reported by a Registered Nurse. The age at vaccination was not reported but it might be 5 year or 6 years. The patient experienced a large raised welt the day after injection that covered either the whole upper arm or upper leg. However, it did not bother or limit activity. The reporter reported that they were seeing this a lot with FLULAVAL, but she did not had the specific numbers or information for other patients at the time of the call. This case had been linked with the case US2017GSK165322, reported by the same reporter for brother of the patient.
Patient has no history of hot flashes and reported significant hot flashes day and night following first dose of covid vaccine. This lasted about a week and then stopped. The hot flashes returned after the second dose and persisted for 6 weeks.
102 fever, severe fatigue, nausea, severe pain in arm by 6:00 PM same evening as vaccine for 5 days. Large goose egg at vaccination site from day of injection through last day of physical therapy, June 3, 2022, for acute tendonitis in arm due to the injection. Pain has radiated into the shoulder joint. Range of motion due to arm and shoulder pain remains limited almost 5 months after the vaccination and six weeks of physical therapy.
Fatigue, headache, muscle pain, joint pain, chilss, nausea, vomiting and low grade fever.   Felt better after 24 hours other than nausea which is still persistent 6 days later.
Pt brought in by EMS 4/24 having weakness on the left side and his speech was a little bit slurred. Denied any chest pain, palpitations, or shortness of breath. Pt COVID positive 4/25 denies any new symptoms besides mild headache. 4/28 pt denies any pain.  Left arm and leg are noted to be flaccid.  Pt remains A/Ox4.  Appetite moderate. 4/29 pt stable, reported weakness, shortness of breath or chest pain. Left arm and leg continued to be flaccid.  Pt c/o headache and medicated x2 with tylenol. 4/30 L side flaccid but pt is able to assist with repositioning. Pt continues to have daily headaches but denies any photophobia or neck stiffness. Discharged 4/30.
Pt returned to health dept for Hep-B and stated he developed dizziness, tiredness, shortness of breath and diaphoresis within 24 hours of Hep-B.
9-6-07 came to clinic for physical - received Tdap, Menactra, and Varicella #2. Symptoms started 9-7-07 - dots around site - changing to rash on second day around site - raised - swollen, turned into 2 long areas - from shoulder to elbow - swollen - warm - red- used hydrocortisone to site - she also c/o SOB, tightness of chest, weak and dizzy. Rash spread to check - chest - legs - size of one-two quarts. Still itches. Pt has hx of STV - in hospital at 3 yrs of age. Returned to clinic 9-19-07 - weak - dizzy - not reported until 9-19-07 visit.
No adverse outcome.  Patient received 2nd dose of Pfizer at 14 days rather than 17 days.  Instructed by provider to give 2nd dose early due to patient being transferred.
Information has been received from a pharmacist concerning a 61 year old Caucasian female pt with an allergy to Duricef and a history of a local reaction to TD in 1999 who in 1995 was vaccinated with the 1st dose of pneumococcal vaccine 23 polyvalent. On 10/30/01, the pt was vaccinated with the 2nd dose of pneumococcal vaccine 23 polyvalent IM in the left thigh (1st number 637261/1067K) and influenza virus vaccine (Fluzone) IM in the right thigh (lot U0600AA). Other concomitant therapy included glucosamine, enalapril maleate, Tums, estradiol, Darvocet and an unspecified medication. Within 24 hours, on 10/31/01, the pt developed a site reaction on the left thigh about 6" in diameter with warmth, redness, swelling, inflammation and pain. The symptoms occurred only on the left thigh, which was the injection site of pneumococcal vaccine 23 polyvalent. The pt also had a swollen face and some swelling and numbness of her mouth, tongue and lips. The pt was started on prednisone 40mg X 10 days. The pt had previously tried Benadryl with little results. The pt's symptoms resolved on 11/14/01. No additional information is expected.
Received vaccination at 1546, at approximately 1925 he was evaluated by medical staff for hives, vomiting, and difficulty breathing.  He was treated on site by medical with diphenhydramine IV, methylprednisolone sod succinate IV, albuterol sulfate neb soln, and ipratropium inhalation soln.  Following treatment he was still with difficulty swallowing and was sent to the ER via ambulance and remains there at this time (1/28/21, 0839)
T. 104 degrees Fahrenheit. Generalized macular, papular erythematous rash. Rash began 8 days after administration of vaccine. No vesicles seen.
Patient received four doses; Patient received four doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 26th November 2019) and Shingrix (2nd dose received on 22nd January 2020).   On 1st November 2020, the patient received the 4th dose of Shingrix. On 1st September 2020, the patient received the 3rd dose of Shingrix. On 1st September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 1st November 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comment: Pharmacist reported that the patient received four doses of Shingrix. Health Care Professional did not have the lot number or expiration date for any of the doses. The reporter consented to follow-up. Additional Supportive Information:  The patient received four doses of Shingrix vaccine, which led to extra doses administered.
Temp of 102.5 for 20 hours and 2 blisters smaller than a dime.