chrisvoncsefalvay/vaers-outcomes huggingface dataset:
snake bite; allergic symptoms; hives and trouble breathing; hives and trouble breathing; Initial information received on 30-Jan-2022 (processed as non case) and follow-up information received on 04-Feb-2022 regarding a unsolicited valid serious case received from the patient.  This case involves a 63 years old male patient who experienced snake bite, allergic symptoms, hives and trouble breathing while receiving vaccine influenza quadrival a-b vaccine (Fluzone QIV).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing highly allergic to animal-based vaccines (Food allergy).    On an unknown date, the patient received suspension for injection suspect influenza quadrival a-b vaccine dose and lot number not reported via unknown route in unknown administration site for prophylactic vaccination. Information on Batch number was requested.  Reportedly patient wants to know if there are any flu shots that do not have any animal products. Patient stated he took the swine and flu combination decades ago and went to the emergency room with hives (urticaria) (unknown latency) and trouble breathing(dyspnoea) (unknown latency). Patient stated he took the antivenom for a snake bite (unknown latency) and ended up in the hospital with allergic symptoms (hypersensitivity) (unknown latency). The reaction to the swine/flu shot was end of 1990's to early 2000. Caller states he was not allergic to eggs since he eats them all the time.   Action taken: not applicable.  The patient was treated with snake venom antiserum (Antivenom) for Snake bite.  At time of reporting, the outcome was Unknown for the event hives and trouble breathing, was Unknown for the event hives and trouble breathing, was Unknown for the event allergic symptoms and was Unknown for the event snake bite. Seriousness criteria: Patient was hospitalized for snake bite and allergic symptoms  Follow up information received on 04-Feb-2022 from patient: Events added: snake bite, allergic symptoms, hives and trouble breathing. Text amended accordingly.; Sender's Comments: Sanofi company comment dated 09-Feb-2022: This case concerns 63 years old male patient who was vaccinated with influenza quadrival a-b vaccine (Fluzone QIV) and at unspecified date after vaccination the patient experienced snake bite. A significant temporal relationship cannot be established due to lack of information on event onset date and vaccination date. Furthermore, information regarding condition at the time of vaccination, medical history, concomitants, lab data excluding other predisposing etiologies, intervention (if any), corrective treatment/medical management, family history, pre-natal genetic study (if any) would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
cough, runny nose, fatigue, body aches, vomiting (resolved), diarrhea x 1.  starting 1/2/22
I am getting severe headaches every day evening starting from 4PM till next day morning and again it triggers in the evening
Received HPV #2 on 3-28-16. No unusual problem initially. Began to be hurtful 4/11/16, palpable painful lump, painful to move arm. Sl. red overlaying skin. Afebrile otherwise well.
Nausea, very cold and shivering, headache, heavy heartbeat, leg thigh muscles hurt. Used lots of blankets to get warm and TYLENOL for headache and pain in legs. Was tired for few days and no energy. Slowly getting energy back.
aprox 1 hr p/vax pt had pain in opposite arm (rt) & drawing of fingers, loss of use in arm (partial); called MD: pt hospitalized w/dx of prob stroke;
Reports vision has been "different" since day of vaccination. Reports as more difficulty focusing. Does have prescription for glasses that she does not wear. Advised patient to wear glasses and report if symptoms improve.
It was red and swollen around the injection site.  On the July 30th there was a red rash around the swollen red area. On August 4th I stopped at the Pharmacy for the Pharmacist to look at it.  She said the rash looked like a light case of Shingles.  On August 19th I noticed I had a red rash on the front of both legs which seemed to spread to the rest of my body.  I was able to see my PCP He ordered a COMPLETE BLOOD COUNT WITH AUTO DIFFERENTIAL - Details.  He didn't believe my rash was shingles because I didn't the rash didn't itch or have the fluid filled bumps. I'm to follow up with the doctor in 2 weeks if not improved. I believe the rash all over my body has something to do with the Shingles Vaccine.
Mom reports that 2 days after vaccine was given patient developed a red and raised area to injection site and fever of 102 degrees. The following day was at daycare and had a witnessed seizure of around 5 minutes. Reportedly had been active prior to seizure and was playing and dancing at daycare. No fever had been reported by daycare provider. Was lethargic after seizure and was taken to ER for evaluation and had blood work done. The following day the patient, according to mom, was acting normal and had no further fever, and no further seizure activity.
Severe pain in injection arm 10 days out; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6202) via an unspecified route of administration in the left arm on 03Mar2021 at 11:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and auto-immune issues. Prior to the vaccination, the patient was not diagnosed with COVID-19. Any other vaccines taken within four weeks prior to the vaccination was not reported. Concomitant medications included asthma inhaler (unspecified) from an unknown date and unknown if ongoing. On 12Mar2021 at 22:00, the patient experienced severe pain in injection arm 10 days out. It was so severe and if it did not stop, the patient would not be getting another shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measure was not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in injection arm 10 days out was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient received varivax vaccine 10/9/95. Complained of chicken pox > 50 spots about 10/11/2002.
Starting hearing a muffled clicking noise in my left ear about a week after my shot. I can slightly feel a thump in my ear  every time it clicks. It?s never consistent how long the clicking lasts, but happens everyday
Woke 6/17 with rash on (L) arm - Injection site swollen and tender (lateral aspect) - Linear rash is medially and extends to axilla 2x10cm - Clean and dry superficial cat scratch is > 5cm distal to it. No fever but c/o fatigue and all over achiness - Rx'd with KEFLEX 500mg TID x 10 days.
left hand numbness - resolved spontaneously followed by headache and  HTN  all resolved spontaneously
pt recv vax 7DEC98 & approx 5wk post vax pt exp peripheral neuropathy which was considered disabling;the neuropathy included vague paresthesia primarily in the hands of both extremities;pt had neuro w/u for MS;p/3rd dose no recurrence of sx. Annual follow-up received on 11/27/00 provides no additional data. Information has been received from a physician concerning a 48-year-old female patient who on approximately 07-DEC-1998 was vaccinated with a second dose of RECOMBIVAX HB. Approximtely 5 weeks after the second dose, the patient experienced peripheral neuropathy which was considered disabling. The neuropathy included "vague paresthesia primarily in the hands of both upper extremities. The patient had a neurological work-up for multiple sclerosis and all of the findings were negative. On approximately 07-DEC-1998, the patient received a third dose of RECOMBIVAX HB and has not had recurrence of the symptoms. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/1/99. Information has been received from a physician concerning a 48-year-old female patient who in approximately 1998 was vaccinated with a first and second dose of RECOMBIVAX HB. Approximately 5 weeks after the second dose, the patient experienced poly neuropathy that was described as "vague paresthesia primarily in the hands of both upper extremities." The patient had a neurological work-up for multiple sclerosis and all of the findings were negative. On approximtely 03-DEC-1998, the patient received a third dose of RECOMBIVAX HB and has not had recurrence of the symptoms. Unspecified medical attention was sought. Upon internal review, the patient's experience were considered to be other medical events. Additional information has been requested. This is an amended report. The adverse event was changed from peripheral neuropathy to paresthesia. The serious criteria was changed from disabling to other medical event. The date of vaccination was changed from 12/07?/98 to 98?. The number of previous doses was changed from 2 to 1. The onset date was changed from 12/??/98 to 98? The date of the diagnostic test was added. The narrative was edited. This a corrected report, as amended.
Swelling in arms, hands, feet and around eyes that appeared approximately 1-2 hours after vaccine.  Drank lots of fluids.  Swelling  was not extreme but enough that I removed rings on my fingers because they became tight. Slight swelling still present 4th day after vaccine. Took 24 hour Claritin on Saturday (12/18) and another today (12/20).  Have vertigo today as well. Contacted  Pharmacy, where I got vaccine today and they told me to contact my doctor and fill out this report. Have contacted doctor and waiting for response.
I received the pneumovax vaccine yesterday. 26 y.o. Female with chronic health problems. I have had the pneumonia vaccine before, at the age of ~21 as I have struggled with repeat pneumonia and bronchitis in the past on a yearly basis. With the coronavirus in mind and my health history I elected to receive the vaccine this year even though it has been a couple of years since I've come down with a bad case of pneumonia/bronchitis. I felt fine after receiving the vaccine yesterday morning but quickly developed general malaise. Symptoms included swelling, redness, warmth at injection site and by the afternoon my chest, arm, shoulder, and back were in severe pain, by far some of the worst pain I've ever felt in my life. It was excruciating. Today I woke up feeling better but the back and chest pain has returned and I now feel nauseous and have resisted the urge to vomit all day. I have no idea what to do or if this will continue into tomorrow.
This spontaneous case, initially received from other healthcare professional on 05-Sep-2018, concerning a 41-year-old adult male patient. The patient's current conditions included high cholesterol, stroke, hypertension and renal failure (reported as medical history). The patient's concomitant medications included furosemide, MEROPEX, azathioprine, lisinopril, metoprolol, felodipine, amlodipine, calcium, baclofen, hydrazine and Aspirin for unknown indications. On 05-Sep-2018, the patient was accidentally administered with 1.5 ml instead of 0.5 ml dose of FLUCELVAX QIV (expiry date: 31-May-2019, batch number: 252227, route of administration, anatomical location: not reported). The Seqirus confirmed that, the batch number (252227) was a valid FLUCELVAX NH1819 QIV MDV 1X10 batch number. It was reported that, the details of adverse event experienced by the patient after vaccination was not known. The reporter assessed this case as non-serious.
Itching, swelling, erythema at site of injection - approximately 2 hrs following vaccination.
I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot; I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown", COVID-19 (medically significant) with onset Dec2021, outcome "recovered" (2021) and all described as "I was at a wedding an a guest mentioned that she had a positive COVID test in late December. She did not have the booster shot". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive, notes: she had a positive COVID test in late December. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Facility type vaccine was Unknown. Other medications in two weeks were Unknown. If covid prior vaccination was Unknown. If covid tested post vaccination was Yes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to an 11 years 9 months old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. 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 is not expected, no contact details were provided.
Mom stated child slept for approximately 3 hours after leaving clinic. (3:30-6:30pm) At approximately 9:00 pm, hives were noted mostly on torso. Child was taken to a Medical Center. Benadryl given in ER and mom instructed to continue Benadryl every 4 hours. Mom state hives resolving by 2:30 am and completely gone later in am on 7/19/06.
Severe bone, joint (all joints) pain, chills, fever, for over 12 jours, slight indigestion. Has gappened with all covid shots (moderna included) so far. I had not reported before. Pain severe alleviatted slightly with 500mg tylenol. Pain is ongoing as of now.
cough, congestion and shortness of breath for 5 days; loss of smell since this morning
Donor noticed soreness in right arm at site 12/08/05 20:00 hrs still sore today 12/10/05. Marked and swelling 12/09/05 2330 hrs same condition 12/10/05 1400 hrs. no treatments
23MAY91 pt unable to walk; t102ax; Seen by MD said this was rxn to Pertussis; 28MAY91 mom reported pt walking by 26MAY & seems to be fine;
Patient reported right side of face red, hot and swollen beginning evening of 03/11/21.  Ear aching. Pain and aching all over the body. Fatigue, nausea, dizziness and loss of appetite.
Information has been received from a physician concerning a female who was vaccinated with Gardasil. After the third dose the patient's menstrual cycle became irregular. Additional information has been requested.
I noticed a 2 1/2 in red rash on her arm 3 days after the immunization (I had not previously looked at the site) The red area is warm to the touch and hard. Also tender. The doctor prescribed Keflex to treat it.
Developed morbilliform drug rash on trunk starting day of vaccine that progressed in days following
Patient describes terrible pain in her right arm. Patient had 2 vaccines administered that day, Fluzone HD and Prevnar 13.  Her right arm with the pain was the arm the Prevnar was administered.  The arm was slightly swollen and very red.  Hot to the touch.  Patient came to the health care clinic where it was administered, and was given a course of antibiotics 10/10 for a possible cellulitis.
Information has been received from a LPN concerning a 6 yr old white male with no medical history who on 28Apr00 was vaccinated SC with a 0.5mL first dose in the right arm of varicella virus vaccine live (lot632619/1861J) (also reported as Lot 1816J). There was no concomitant therapy. The LPN reported that on 19Apr05 the pt developed lesions all over body on his torso, head, under axilla, in the underwear area and face. The pt was noted to be afebrile. On 21Apr05, the pt was seen in the physician's office. No lab/diagnostic tests were performed and the pt was treated with diphenhydramine HC1 (Benadryl). At the time of this report the pt's lesions persisted. Follow up information from a licensed practical nurse indicated that on 19Apr05 the pt experienced a itchy rash with vesicles and scabs in different stages all over his torso, arms and legs. It was reported that the pt recovered. Additional information is not expected.
she had an rash on her throat; This spontaneous case was reported by a consumer and describes the occurrence of RASH (she had an rash on her throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (she had an rash on her throat). At the time of the report, RASH (she had an rash on her throat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided.  No treatment medication were provided.   Reporter did not allow further contact
Continuous shoulder pain without loss of range of motion. Patient is still experiencing the pain as of today. Patient took ibuprofen and massaged the area, with minor relief.
Swollen throat, numbness on half of face, itching, slow speech, flushing, body aches
chills, severe fatigue, body aches, (developed diaphram cough) next day was gone
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable Consumer (patient).  A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient tested positive to covid-19 in Jan2021 (last week) with outcome of unknown. The patient wanted to know when he should receive the second dose.   No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
I vaccinated one of our patients on Friday 09/18/2020 (Fluad and Pneumovax), both vaccines on the left upper arm. Patient came in on 09/20/2020 Sunday and was saying that her arm was swollen, painful to touch and was in a lot of discomfort. I noticed that the swelling was mostly little away from the injection site, extending down the upper arm towards the elbow, but not on the elbow. Followed up with patient on Monday 09/21/2020 around 5pm and she said there was not much improvement. Followed up another call to patient on Wednesday 09/23/2020 - had to leave message on voice mail - no reply from patient. S/W STAFF @ MD's OFFICE & NOTIFIED (9/30/20) PT. CAME IN STORE DRIVE THRU ON 10/2/20 & SAID SHE WAS DOING WELL & NO MORE SWELLING!
Both vaccines given on (L) upper arm - 1 inch apart, per patient report. Short time thereafter, started developing erythema. Area of erythema and swelling enlarged over the next 2 days (area separate from where inj. administered). Also, patient reported headache.
8 hrs of crying p/1st DTP, relatively unconsolable, subsequent complete recovery;
As per Dr pt needs Hep B titers, 3rd dose was given before date. Also she does not give HIB after 2 years old.
RN: called AID for a guest complaints of "brain fog," and feeling her blood pressure was elevated. B/P 142/78 when assessed. Guest reported a similar sensation when she received her first dose and this lasted for about four hours. Guest had some water  B\P 140/78 rechecked and she states that she was fine and declined continued observation.
April 23: rash occurred on both legs with significant amount on left leg . Rash was very itchy but consisted of small bumps (some with what appeared to be clear liquid) with surrounding area being slightly red/pink.     * already on Zyrtec (10mg, 3 pills in morning) April 28: Rash did not improve, still very itchy.     * Went to clinic, was prescribed Hydroxyzine HCL 25mg (1-2x/day, taken at night) and Triamcinolone Acetonide cream 0.5% (3-4x/day) in conjunction with Zyrtec and Allegra (180mg, 1x/day).  April 30: rash had worsened significantly in size, bumps, and redness. Rash still very itchy.     * began oatmeal baths, eczema cream with 2% colloidal oatmeal May 10: rash had not improved. Went to dermatologist, had biopsy. Informed to take 20mg Pepcid 2x/day and stop using Triamcinolone.     * within a few days of not using Triamcinolone, rash began to improve and become less itchy, less red, and less raised from skin. Continued aforementioned medications and treatments. May 18: rash almost completely gone, areas of breakout no longer pink or raised from skin, itching has mostly subsided.
Pt developed a 10cm x 10cm erythematous raised pruritic lesion at injection site. No systemic reactions were noted.
Itching at site and dry cough started within 1-2 hours after injection. Cough became congested after a few hours. 12 hours after injection, I had chills, extreme shivering, teeth chattering, fever, sweats, body aches, joint pain, headache, nausea, fatigue. These symptoms went away in about 12-18 hours, including the cough. Took tylenol .
This spontaneous report as received from a licensed practice nurse refers to an unspecified number of patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M007764, expiration date 30-JAN-2018; dose and route of administration were not reported. There was no adverse effect reported. Administered doses of vaccines had been stored at the temperature of 0.5 degrees Celsius for 2 months and 8 days (date unspecified). A digital data logger was involved. There were no precious temperature excursions reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.
pt recv vax 26NOV97 & 28NOV97 pt exp ecchymosis @ the inj site;pt also exp hives;one hive occurred in the area of the rt eblow (7.5c5.5cm) & another hive devel later on the rt upper thigh (4x2cm) ont he outside side;