chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IPOL (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: Yes, with no reported adverse event; IPOL (opened) exposed to a temperature excursion was administered to the patient with no reported adverse event; Initial information received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 6 months old female patient who was administered IPV (VERO) [IPOL] (opened), which was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine for Prophylactic vaccination.  On 12-Jul-2023, the patient received 0.5 ml dose of suspect IPV (VERO) (frequency: once; strength: standard) Suspension for injection of lot V1A021M and expiry: 27-Feb-2024 via intramuscular route in unknown administration site for immunization.  On an unknown date, it was reported that the suspect IPV (VERO) (opened) was exposed to 3 separate excursions; total: low of 1.85C for 30 minutes and a high of 8.74C for 60 minutes; reason: accidentally left the refrigerator door open too long; human error: yes, with no reported adverse event (product storage error) (unknown latency).  On 12-Jul-2023, the patient was administered IPV (VERO) (opened) exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency: same day).  No lab data was provided.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events product storage error and poor quality product administered.  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.
consent signed for covid vaccine #2. given at 10 am. Shortly aftr at 1004 am pt started to c/o feeling warm like a hot flash to the left arm going to her back and neck.   Pt using her non invasive ventilator at this time, continue to observe. 1015 pt c/o lips numb, warm sensation,tingling to both arms and throat feels funny.  called for Dr. to come to see pt.  1020 am  Dr. here to assess pt.  BP 180/88,  O2 sat 93%, pulse 68 lungs clear.  1025 Epi 0.3 mg  given to the right arm IM, 1029 another Epi 0.5 mg givne IM to the right deltoid IM per Dr.'s verbal order.  No wheezing. 1035 unable to get reading for O2 sat, both hands are cold to tough,  apical pulse was 80/min. resp 24, continues to use her non invasive respirater,   1043 am   Aftr warming her hands SaO2 96%, pulse 67, BP 180/80.  1058 am  Dr. was called , pt C/o feeling funny ,lips swollen and now below her left eyebrow is swelling cheeks feel puffy, lower lip swelling, SaO2 97%,  BP 190/88, pulse78.  1106 am  EMS has been called for transport to hospital for observation  Verbal order from Dr. to give another epi 0.5 mg IM-to the left deltoid.  1108am c/o light headednes, pulse thready.  1114  Lungs are clear Sao2 98%. c/o dry mouth c/o face feeling puffy, and feeling jittery.  BP 228/110.  1128 am   EMS arrived.  Dr. discussed  pts mode of transpor, fire department called to assist with pt transfer to gureney.  Pt dischargd to EMS at 1145 am. ................................................................... RN  April 22, 2021 3:52 PM
This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)) in a 21-year-old female patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)). At the time of the report, MENSTRUATION IRREGULAR (second dose of the Moderna COVID-19 vaccine also set off menstruations at a time where I should not have gotten them. (2 weeks after my previous cycle's bleeding had stopped)) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-443290, MOD-2022-441878, MOD-2022-445119 (Patient Link).
I had no immediate reaction at all to the vaccination.  I awoke the next morning with only moderate pain and warmth at the injection site.  However, 24 hours after the injection, I started developing isolated very small areas of itching -- these were tiny raised itchy spots, almost specks, that were either red, light pink, or colorless. The spots were very far apart from each other on my chest, abdomen, arms, legs, and scalp -- they did not cluster into any kind of rash formation.  I would say that there were 10 to 20 spots at any one time, which would fade away, and then others would occur.   I think the occurrence of these itchy spots may have interfered with my sleep (or maybe it was anxiety or something else from the vaccine), because I was practically sleepless the first night that this occurred.  By 60 hours after the vaccination, the itchy spots were appearing with less frequency, and now 80 hours post-vaccination, there are only a few, although there are still new ones occurring.   I am not reporting this as a major adverse event, but  I wanted to document it for your records and because it would have been helpful and reassuring for me to find online information about such a reaction  when it was at its worst.
ZOSTAVAX administered 8/4/15. 8/5/15 c/o nausea, dizziness, later that day pt reported fever of 104.8/6 pt reported fever of 102-seen by dr. 8/7 c/o penile swelling-seen by dr and urologist. Started pred pak. 8/10 c/o rash on penis. 8/11 still with swelling, pain, rash on pens-seen by urologist again. 8/14 pt states he about 50 % better.
pain at the injection site; sore arm; This is a spontaneous report from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms via a non-contactable consumer (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had now had both doses of the Pfizer COVID-19 vaccine. It has now been several days from the second dose. After 1st dose, she had a sore arm and some pain at the injection site for about 24hrs. Definitely sore that evening when sleeping and was difficult to sleep on that side. After 48hrs so more pain. No other symptoms! Events outcome was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt seen in Family Planning Clinic - given TDAP and Depo - Pt states she had nausea & vomiting, tenderness at injection site, headache, and fever 101 degrees began 9/21/pm.
Approx 3/16 I noticed a rash/welt developing on my left arm, but couldn't figure out what it was from. This evening I looked at it more closely and realized it Starts at the injection site and his downward approximately 2 inches, then another small cluster. It does not itch very much, and is only slightly raised from the skin.
4" long rash, 1.5"  wide on the bottom of the left arm, warm and sore to the touch with a lumpy feeling that isn't visible. Taking  an antihistamine for a week, which has taken care of most of the rash, but the lump is still there upon palpitation
It was red (some) on the evening of the shot by the next day my arm was swelled big red to elbow and up to shoulder almost all around very painful. My stomach hurt really bad it got worse the next day. I was told to put heat compresses and keep it moving and it got better in five days was back to normal.
Presented to clinic 3/24/03. Fever off and on since last Saturday 3/22/03 as high as 103 and 104. Has 10 chicken pox lesions. Previously vaccinated with Varivax on 2/16/01. Clinic was instructed to check temperature logs to see if vaccine was properly stored.
This spontaneous report as received from a 70 year old female patient who is also a healthcare worker and who was reporting on herself. The patient's pertinent medical history included hypertension and benign breast mass. The patient had an allergy to ampicillin, penicillin and KEFLEX. Concomitant therapies included ramipril, MOTRIN and simvastatin (manufacturer unknown). On 24-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose and route were not reported, lot # K018172, expiration date 02-DEC-2015). On an approximately 24-MAR-2015 (reported as approximately 4 weeks after), the patient experienced fever blisters, itching, nodules in back of head and side of her face and swelling on her lips. The patient did not seek a medical attention and did not receive any treatment. There was no lab diagnostics and studies performed. The patient's outcome was not recovered/not resolved. The relatedness between the event and therapy with ZOSTAVAX was not provided. Additional information has been requested.
Sought treatment for neck shoulder arm pain on the right. She received her first SHINGRIX vaccine on 8/1/18 on the left arm and when she went to go-health yesterday (8/15/18) she was told that her pain was "kinda like shingles". She was not diagnosed with shingles, but her pain, dull constant aching from her hairline down to her elbow on her right that inhibits her ability to put her ear to her shoulder and sometimes turn her head to the right seems consistent with pain frequently experienced by shingles patients. She does not have fever, rash, coryzal symptoms at this time. States that discomfort started on Tuesday (8/14/18), sought care yesterday (8/15/18). Prescribed muscle relaxants that did help her sleep last night. Tiger patches have provided some relief as well. Concerned that symptoms are related to SHINGRIX vaccine received 2 weeks ago. Also received PREVNAR vaccine 7/2/18 in right deltoid. Site was initial sore, but it improved to baseline. Concerned that severe neck and right arm pain are vaccine reaction.
On 2/21/07 presented to clinic with bilious emesis and bloody stool. Infant was afebrile was not found to have intussusception by ultrasound. Infant recovered uneventually.
Chills, headache, body aches, night sweats, nausea, I had covid in fall 2020 and these symptoms were worse than when I actually had covid
the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."/The patient had significant disability as patient was having significant pain in his left arm.; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; the patient developed "chills, shaking, flu-like symptoms, redness at injection site, swelling of arm from injection site to elbow, and pain in left arm."; This spontaneous report was received from a pharmacist, referring to a 64-years-old male patient. The patient's concurrent conditions and historical condition were unknown by the reporter. It was reported that the patient did not have previously drug reactions or allergies. The patient's concomitant therapies included atorvastatin and losartan.     On 08-AUG-2019, the patient was vaccinated for first time with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly in his left arm (strength, and dose were not reported; lot number R034249 has been verified to be valid for pneumococcal vaccine, polyvalent (23-valent); expiration date 07-AUG-2020) as prevention of pneumonia..      On the same date a couple hours after receiving the vaccine, the patient developed chills, shaking (tremor), flu-like symptoms (Influenza like illness), redness at injection site (vaccination site erythema), swelling of arm from injection site to elbow (peripheral swelling), and pain in left arm (pain in extremity). Consequently, The patient sought for medical attention, he went to the pharmacy to reported the symptoms. The pharmacist reported that the patient had significant pain in his left arm. However, he did not received treatment for the events, and lab diagnostics/studies was not performed.   At the time of this report, the outcome of the aforementioned events was reported as resolving.        The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events occurrence was not reported. The event pain in extremity was considered disability by the reporter.
Severe headache x 2 weeks, neuropathy in bilateral upper and lower limbs, feeling unwell a general malaise, weakness, tiredness, sharp pains in my legs and head, dizziness, off balance, all lasting for about 2 weeks or so is when I started to get relief I still have a lingering headache and neuropathy.
I started to experience a headache, arm pain right away and a little pain in my knee. I was feeling fatigue and my knee pain started to increase. I am still experiencing pain from time to time in my knee. The pain in my shoulder has been excruciating still. I'm having a lot of trouble with using my arm pain.
Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 19-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Achy-ness of muscles and skin; general feeling of being unwell; short episode of chills
Today, the patient presented back to the immunization clinic and reported that the reaction started three days ago with itchiness and warmth on her left posterior, upper arm where she received her Varicella vaccination on January 21, 2014. The patient reports that two days ago she had a headache and then she noticed a red, raised area on her lower, right, anterior neck. The patient reports that the next day she had two additional red, raised areas on the lower, left quadrant of her abdomen. The two areas are about one-half inch apart from each other. One of the areas appears to have an entry point. Today, she noticed that had a red, flat area on her left, upper shoulder. All of the red areas previously noted were closed and dry and approximately the size of a quarter. Patient's mother was given driving directions to the nearest emergency room and instructed to go there immediately after leaving here.
7 days post shot; itchy arm at injection site; raised, hive-like area approximately 2 inches in diameter; warm to touch
Itiching at the injection site (3 weeks after injection) pain at the injection site, small welts appeared a few days after that.
1st vaccine: Chills, shivering, teeth chattering, 104 fever, tired.  Fever lasted 24 hours. Taking Tylenol and Ibuprofen every 2hrs (difficulty controlling fever). Signs and symptoms lasted 2-3 days.   2nd vaccine: Within an hour felt right arm tingling and warm. Then started to move up neck and into right ear. That evening chills, shivering, teeth chattering, 103 fever, tired. Fever lasted 24 hours. Taking Tylenol and Ibuprofen every 2hrs (difficulty controlling fever). Lasted 2-3 days. Right arm (injection site) red, warm, swollen and very tender (clothes hurt when touching skin) x5 days.
Hives on neck, chest, back and groin. Mother called nurse at state health center who directed her to go to ER (child had no swelling of the face, tongue or lips, no respiratory distress). Child treated with Benadryl and oral steroid (Prelone). Spoke with mother 9:00am 7/17/15, child slept well and much improved this morning, hives clearing up, almost gone.
1OCT93 8AM noted rash, red blotches @ site of inject of lt arm; cont anterior upper chest & upper lt back;
pt recv vax 11AUG95 & 5JAN97 pt devel a breakthrough case of chickenpox which was classified as mild, w/20 vesicular lesions scattered diffusely;pt was reported that pt did not have any other concomitant conditions;
happy unexpected improvement; general fatigue; The initial case was missing the following minimum criteria: unspecified product, unspecified adverse event and unspecified number of patients. Upon receipt of follow-up information on (17Apr2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570).  An 84-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2022 as dose 3 (booster), single (Lot number: FF2590) at the age of 82 years for covid-19 immunisation. The patient's relevant medical history included: "vascular dementia alzheimers and parkinsons" (unspecified if ongoing); "vascular dementia alzheimers and parkinsons" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , Lot: EL3246), administration date: 07Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "cognitive improvement", "general fatigue"; BNT162b2 (DOSE 2, SINGLE , Lot: EL3246), administration date: 28Jan2021, when the patient was 81-year-old, for COVID-19 immunization, reaction(s): "cognitive improvement", "general fatigue". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "happy unexpected improvement"; FATIGUE (non-serious), outcome "unknown", described as "general fatigue".  Additional information: This is not an adverse negative reaction but rather a positive side effect. At both initial vaccines patient (reporter's mother) experienced a (Illegible word) cognitive improvement. More alert and responsive as if to suggest an arresting of disease process. She had vascular dementia alzheimers and parkinsons. Both of which degrade overall awareness and interactive responsiveness. Beyond a pronounced general fatigue which is the understood effect of any vaccine on the body, the happy unexpected improvement which seems to occurred with any revaccination of pfizer covid vaccine. Reporter reported for the record that research may result. One or more of the chemicals or chemistry of this product could prove useful in the fight of both alzheimers and parkinsons.
Patient received (PEDS) children's dose of Pfizer COVID vaccine instead of adult dose.
First day after receiving vaccine - fever (102 deg), body and head aches, ringing in ears, tiredness  Day two, also experienced strong tingling in feet and partly up the left leg (mid calf). When walking, noticed numbness in feet and also weakness in keeping ankle stable. Also noticed numbness in groin area, primary on the penal shaft.  Day three - day one symptoms have subsided, whereas day two symptoms persist or have increased somewhat.
Headache PROGRESSIVELY WORSENING FULL BODY ACHES, LOW ENERGY
PATIENT HAD CALLED THE PHARMACIST AND STATED THAT HE WAS GOING TO FAINT. HE HAD TURNED PALE, HYPERVENTILATED, DIAPHORETIC. EMS HAD ARRIVED BY 7PM AND GOT THE VITALS, BLOOD PRESSURE, O2 SATURATION, PULSE WERE OK.
Right after immunization patient alert APN monitoring are "Tickle" in her throat and "taste of metal". Then patient started experiencing tachycardia, shortness of breath , and continuously clearing her throat. 02:03pm- BP 130/100, pulse of 96, O2 88%. 2:04 pm--patient experiencing  "hot potato voice" and sensation of back of tongue. EPI pen was administered at 2:05 pm. 911 called. 2:08 pm- Benadryl 50 mg IM given. 2:09pm- patient reported some improvement,  feeling like she could breathe easier. BP 140/110, pulse 85, O2 93%.    2:11pm- patient transferred to ER via EMS. Later EMS reported had give patient a 2nd dose of EPI due to SOB and wheezing.
Right deltoid site red, swollen (baseball size) since yesterday. 10/22/02 Headache, body aches, nausea since 10/22/02.
24 days p/vax fussy, t101 seen @ clinic; MD dx URI; 27 days p/still w/fever, mild URI sx; began sz; LP showed glucose 49, protein 110; 4RBC, 185 WBC, 17% POLY, 83% Mono; all other lab ok; dec use of extremities; all resolved;
A spontaneous non-serious report of administration of extra dose has been received from a nurse practitioner concerning a five year old male patient subsequent to FLUMIST. Medical history and concomitant medications were not reported. On 15-Dec-2008, the patient received one dose of FLUMIST and on 17-Dec-2008, the patient received FLUMIST again. There was no adverse event associated with this vaccination error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report as received from a registered nurse reporting on a fellow colleague. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was topically exposed to VARIVAX in an unspecified eye "during preparation". No adverse effects reported. The nurse stated it was unspecified how the VARIVAX vaccine got in to their colleague's eye however the nurse did confirm that no quality issue was involved. Additional information has been requested.
Flu like symptoms for 24 hours starting about 3 hours after shot. Nausea included.
Patient passed out while in observation after receiving the vaccine. A passing customer noticed patient was in distress and asked for his wellfare. Patient returned back to consciousness and asked to have someone check on him. 911 was contacted and firefighter department advised not to give him water. He was not taken to the hospital.