chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 15-OCT-2009, the patient was inoculated with the ZOSTAVAX vaccine at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 04-AUG-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
I started having menstual spotting 4 days after the vaccine. I have never spotted in between periods Prior to this.
9/8-9/13/02: pain in R hip (unable to walk), patches-pustules upper half of R leg. Dx: toxic synovitis hip; shingles. Motrin and Tylenol, Depakote. Follow up information received 10/10/02 fromthe reporter states "The Mass Dept of Public Health said after this report was filed that it should not have been considered an adverse vaccine event, even though they stat4ed that initially".
Patient received his 2nd dose 13 days early (2nd dose received on day 8 and not day 21).
POST VACCINE FOLLOW UP BY RN, MOTHER REPORTED THAT PATIENT HAD TEMPERATURE OF 101.6 RECTALLY. TYLENOL 80mg SUPPOSITORY GIVEN BY MOTHER. RN INSTRUCTED MOTHER TO GIVE COOLING MEASURES, INCREASE HYDRATION, IF SYMPTOMS WORSEN TO BRING PATIENT TO ER.
A report was received from a health care professional on 10/23/03 concerning approximately 10 pediatric vaccinees less than 4 years old, of unknown sex, who were inadvertently administered Fluvirin vaccine between 10/8/03 and approximately 10/22/03. Between 10/8/03 and approximately 10/22/03, approximately 10 pediatric vaccinees less than 4 years old were inadvertently administered Fluvirin vaccine. No adverse reactions were recorded at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 12/9/03: A follow up report was received from a health care professional indicating that a one year old male vaccinee inadvertently received Fluvirin on 10/14/03. On 10/14/03 the vaccinee inadvertently received 0.25ml Fluvirin. At the time of reporting the vaccinee did not exhibit any adverse symptoms. No follow up pending. All information received.
Leg swelled up 6 cm hot area, refusal to walk, extreme local pain requiring narcotics.
swollen eyes; swelling of face 'it was in my sinus'; Tired; The initial case was missing the following minimum criteria: no AE. Upon receipt of follow-up information on 17Aug2021 this case now contains all required information to be considered valid.  This is a spontaneous report from a from a contactable consumer via the Pfizer sponsored program.  A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EM9809), dose 1 intramuscular, administered in arm left on 12Feb2021 at 12:30 (at the age of 68-years-old ) as single dose for covid-19 immunisation.  Medical history included back pain and high cholesterol. Concomitant medication(s) included ibuprofen (ADVIL 12HOUR) taken for back pain; atorvastatin 20 Mg taken for high cholesterol; ubidecarenone (COQ-10) taken for an unspecified indication, fish oil taken for an unspecified indication; colecalciferol (VIT D3) taken for an unspecified indication,  magnesium taken for an unspecified indication, chondroitin sulfate sodium, glucosamine hydrochloride, manganese gluconate, sodium borate decahydrate (GLUCOSAMINE & CHONDORITIN) taken for an unspecified indication and monascus purpureus (RED YEAST RICE) taken for an unspecified indication.  The patient reported that after the first vaccine, she woke up the next morning on 13Feb2021 with swollen eyes/ swollen face, 'it was in my sinus'.  She took benadryl & within 2 days she was fine. Just tired. The outcome of the event tired was unknown.   Follow-up attempts are completed. No further information is expected.  Follow-up (26Aug2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075506 same patient/ dose 2
By the next morning I was very nauseous, fever, body aches, temperature, very thirsty, arm hurt, when I got up.  It got worse during the day.  Could not eat all day.  Slept a lot during the day on and off.  By evening felt a "little" better but still had all the side effects.  Slept well that evening and the following morning felt better.  As today has gone by, it is 4:30 PM and am feeling a lot better.  So total of 48 hrs. after injection I had the adverse events.
Patient developed sudden onset of upper extremity tremors, shaking, and anxiety at 3:25 pm and reported to ED for evaluation at 4:25 pm.
Teacher noted fatigue in the AM. Fever checked at noon--103.3.  Student was sent home with family for rest and care.  MD notified and VDH called to inquire if this report was required.  They advised "Yes."
in the morning I vomited; I had diarrhea; One hour ago when I saw my temperature it was 100.1 F; Yesterday I did not sleep well; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01AB21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced SLEEP DISORDER (Yesterday I did not sleep well) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg 2 TABS. At the time of the report, SLEEP DISORDER (Yesterday I did not sleep well), NAUSEA (nausea), VOMITING (in the morning I vomited), DIARRHOEA (I had diarrhea) and PYREXIA (One hour ago when I saw my temperature it was 100.1 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.1 (High) I saw my temperature it was 100.1 F.     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 includes MegaRed Omega 3s & Krill Oil, URINOZINC 320mg QD taken for 10 days.
During injection of flu immunization (IM) on 03DEC2018, administrating employee placed the needle too high on the shoulder possibly affecting the joint instead of the muscle. Patient was in pain initially and still sore weeks after the incident. NSAIDS were prescribed for pain, and physical therapy for physical strength/range of motion.
Within an hour I had a bad taste in my mouth and excessive saliva. The excess saliva stopped within an hour or so.  The bad taste remained into the evening. 7 to 10 hours later I had a fever of 103F and felt very week and tired with body aches.  I rotated Ibuprofen and Tyleonl and my fever ran between 101F and 103F for 24 hours after the fever started the evening after the shot.  The extreme flu like symptoms lasted about 36 hours from onset the evening after the shot.  over the course of 48 hours thereafter the symptoms gradually improved to the point where I felt just fine.  I also experienced minor left arm pain from the injection. My arm was killing me for a week after the 1st injection!
This spontaneous report as received from a physician refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 25-JUL-2016, the patient was vaccinated with an improperly stored dose of VAQTA 25/0.5 ml, 0.5 ml once, intramuscular (dose number, anatomical location, lot # and expiration date were not reported). No other suspect therapies or concomitants were reported. It was stated that VAQTA experienced temperature of 46.8F for a time frame of 20 minutes. There were, reportedly, no previous temperature excursions. Moreover, despite this temperature excursion, no adverse effects were reported and no product quality complaint was involved. Additional information had been requested.
22MAR93 recvd vax 230-3PM approx 4PM started screaming w/cont screaming/crying for next 4 1/2 hrs; 23MAR93 9AM till 330PM went into deep sleep uanble to awaken; p/that was limp & sleepy but would respond; no fever @ any time;
2 female pt in their late 20's recv 2 doses of vax; lab evaluation revealed a lack of seroconversion for both pt's.
Patient reported feeling light-headed and dizzy on day 3 after receiving the 2nd dose of the COVID-19 Vaccine. Patient is a Physical Therapist and was working with patients when she started feeling like she might pass out. Her co-workers took her to the ER, where she was treated with fluids. Patient reported the hospital lab work showed she had low magnesium. She followed up with her physician and the physician reported to the patient that she had low iron.
4-5 days after vaccination- started with chest pressure and tightness. Elevated heart rates, heart palpitations, dizziness, fatigue. Symptoms lasted 2+ weeks. Chest tightness has lessened.. Elevated heart rates remain- occasional dizziness.
Adult patient received Havrix pediatric; Adult patient received Havrix pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 29-year-old male patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 26th August 2022, the patient received Havrix pediatric (intramuscular) .5 ml. On 26th August 2022, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 26-AUG-2022 Reporter's Comments: Adult patient was given 0.5mL pediatric dose of Havrix in the right arm. Call was transferred for further assistance.  The reporter consented to follow up. Additional Supportive Information: Adult patient received pediatric dose of Havrix which led to underdose and adult use of a child product.
This spontaneous report as received from a physician refers to several patients of unknown age. The patients were vaccinated with VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX for shingles. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was not known if the patients sought for medical attention. Follow-up information has been received from the physician via a telephone memo on 10-AUG-2012 concerning that 12 patients were administered VARIVAX (Merck) instead of ZOSTAVAX. The physician did not want to provide any patient identifiers, but stated that the clinic was making follow-up calls at the time of reporting to 9 patients who would be vaccinated with ZOSTAVAX 2-3 weeks later.  And this is one of the 9 patients. No further information is available. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous report as received from a pharmacist via a company representative refers to a 22 year old female patient. It was reported that the patient was not pregnant. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient came to the reporter's pharmacy with a prescription for VARIVAX injection, but they did not have any in stock. Therefore, the patient was instead vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot # and expiry date were not reported) by the pharmacist. After administering the ZOSTAVAX, the pharmacist placed a call to the patient's physician and the physician reportedly said it was fine that the patient received ZOSTAVAX. There were no concomitant therapies reported. No adverse events were reported. Additional information has been requested.
Swollen and painful left axillary lymph nodes for 3 days starting 1 day after the vaccine
Feeling very delirious, weird confused mental state. Feel like I have a lower level of consciousness, experiencing memory loss, inability to concentrate, eat and sleep. Fearing encephalopathy, started around 18-24 hours after vaccines administered.   Arm also still in excruciating pain - hurts to move shoulder, but hopefully this will subside soon.
Information has been received from a registered nurse who heard from another contact concerning a 22 year old female patient who was vaccinated with a dose of GARDASIL. After receiving vaccine, the patient experienced multiple sclerosis. The nurse stated that this was not one of their patients. At the time of reporting, the outcome was unknown. The patient sought unspecified medical attention. Attempts to verify the existence of an identifiable patient has been unsuccessful. Upon internal review, multiple sclerosis was determined to be an other important medical event. No further information is available.
Patient developed fast heart rate and shortness of breath 1 day after vaccine, then a very pruritic morbilliform rash 1 week later.
1/26 Vaccine 10am - sore arm 5pm  - vomiting. Lasted for 14 hours. Between 8-10:30 I had body chills, shaking; teeth chattering / lips were blue. Body aches. Felt like 'heinous flu'.  1/27 10:30am last episode of vomiting. Took Zofran in middle of night (old prescription / 4mg). Could not sleep. I 'felt like i was drunk / dizzy'. Couldn't lay down and close eyes. I was awake all night.  **COVID + ; 03/2020 - was not officially tested
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient lost conscious on his way out of the store down aisle 2. Mother screamed for help. When I went over patient was alert and responsive. Asked patient and mother if they prefer I call an ambulance, both declined. Patient states no history of syncope after injections. Had him transition from lying on floor to sitting on floor, then sitting on chair, and then eventually standing on his own. Patient stated he felt fine and was ok to go home.
A 33 year old female developed nausea, headache, clammy skin, and a small area of induration at the injection site after immunization with RabAvert.  The patient received her third dose of RabAvert for pre-exposure prophylaxis on 05/06/2004.  On 05/06/2004, thirty minutes post immunization, the patient complained of nausea, headache, clammy skin, and small induration at injection site. The patient had a complete recovery of all the adverse events.
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in an adult female patient who received SHINGRIX for prophylaxis. On 17th July 2018, the patient received SHINGRIX. On 17th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching. The patient was treated with ASPERCREME. On an unknown date, the outcome of the injection site itching was recovered/resolved. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had vaccination for shingles on 17th July 2018, since then where the shot was given the patient had severe itching on upper arm, it had just quit itching about a week ago on 1st September 2018. It was so bad the patient could not sleep without ASPERCREME on it. The patient questioned if it could be a reaction to the shot and at the time of reporting the patient was afraid to get the 2nd one which she knew she needed to be immune.
Had flu shot at 10:18. By evening meal he was to tired and weak to eat, so wife feed him. Had chills and body aches and weakness and shaky. Started feeling better the next day.
The patient called yesterday (12/30/2021) and said she had intense pain at the time (and location) of injection of the vaccine (for her booster). She explained that she's now been dealing with pain for the past three weeks and she will be seeing her doctor next week. She is having difficulty opening her middle finger (when trying to open from a fist). I advised her to definitely go to the doctor next week as soon as she was able to get in, and to let us know if there was anything else we can do to help her.
Approximately 15 minutes after the Moderna covid vaccination, patient reported tingling in the left hand. The vaccine was administered in the left deltoid.  Patient denied other symptoms.  BP left arm was 132/80, pulse 68.  No respiratory problems.  Monitored patient again for approx 10 more minutes, no further reactions noted. Patient was permitted to leave. Advised to call the office or report to the ER with any further concerns.
Redness at injection site - slight knot, slight warmness. Pt to apply ice, use ibuprofen and Benadryl cream and watch for other sx.
Systemic: Rash (other than injection site)-Mild, Systemic: Headache-Mild, Systemic: EpiPen was given by nurse. Her vitals were fine 140/82, Oxy 98%. 2 benadryls were also given. Pt will be pretreated before second dose
WHITE/BLACK SPOT IN FRONT OF EYES; SLUMPED ON FLOOR; DRENCHED BY SWEAT; FEELING COMPLETELY DOWN; MY BODY IS FEELING PAIN AS IF IT WERE CURSED AS THAT OF GARLIC OR GINGER IN MACHINE, FROM TEMPLE (SIDE OF THE EAR BACK) SEEMS WILL GO OFF FROM MY BRAIN, NECK, SPINAL CORD, CALF ARE GETTING CRUSHED; EVERY BIT OF BONE TURNING INTO BONE POWDER; COULD NOT GET UP; LOSS OF CONSCIOUSNESS / HEAD BUMPED ON THE GLASS DOOR THEN LOST EVERYTHING; FEELING UNEASY; COULD NOT SLEEP THE WHOLE NIGHT; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, 1 total administered on 17-SEP-2021 13:30 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-SEP-2021 (Friday), after 18:00 the patient started feeling uneasy and could not sleep the whole night. On 18-SEP-2021, in the morning the patient tried to get up but could not get up, felt white/black spot in front of eyes. On the same day within a second or two the patient slumped on floor and experienced loss of consciousness / head bumped on the glass door then lost everything. And reported that when consciousness got back the patient was found completely drenched by sweat as if somebody poured buckets of water, the patient feeling completely down and feeling body pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed, and every bit of bone turning into bone powder. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of consciousness / head bumped on the glass door then lost everything on 18-SEP-2021, had not recovered from feeling completely down, and the outcome of feeling uneasy, could not sleep the whole night, could not get up, white/black spot in front of eyes, slumped on floor, drenched by sweat, my body is feeling pain as if it were cursed as that of garlic or ginger in machine, from temple (side of the ear back) seems will go off from my brain, neck, spinal cord, calf are getting crushed and every bit of bone turning into bone powder was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210936160-covid-19 vaccine Loss of consciousness/ head bumped on the glass door then lost everything. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 AM had severe pain in left arm, could not move it. Experienced light-headedness, all over body ache. Arm pain was so bad i didn't want to move. couldn't sleep all night.  tried to eat breakfast but got dizzy, cold and clammy, couldnt eat. Stayed in bed until around 5 PM because of arm pain and general malaise Was finally able to eat and took a tylenol and fell asleep as light-headedness abated and arm pain was better. Next day was better but couldn't lift arm well until 15th still some pain to this day
This spontaneous report was received from a registered nurse who refers to multiple unspecified patients of unknown age and gender. Concurrent conditions and medical history were not reported. The reporter stated that on 18-FEB-2016 or 19-FEB-2016, the unspecified patients were inadvertently administered stored doses of PROQUAD (Merck) (lot # L034932, expiration date: 03-MAR-2017, dos and route were not reported), on unspecified dates. No concomitant medication was reported. The storage temperature was -13 C degrees, the time frame was 10 min and there was no previous temperature excursion. No adverse effect was reported. This one of several reports received from the same reporter. Additional information has been requested.
Weakness, Fever 102.1 F,, chills, aches beginning within 6 hours of vaccine and lasting 48 hours.  Arm pain with knot in axillary area and night sweats lasting approx 2 weeks.   Positive pregnancy test 4/13/21 with abrupt miscarriage 4/27/21.
Pt reported he got on airplane in morning, his arm got all red and inflamed all the way down, he stayed in bed for 2 days, then went to hospital.
severe vertigo, nausea, vomiting required ER visit vertigo still existing one week later
02/24/2021 Vaccination; 06/2021 Started to experience L shoulder pain; upper arm pain. Positionally midway between shoulder and top of the elbow, where they administered the injection, 'that general area'.  Positional, burning pain. If I raise my arm, it is a burning pain. If I am sleeping and raise arm, it awakens when sleeping. I need to massage the area to diminish it and get back to sleep. This may not have to do with vaccine but the timing was such I felt should be shared with the CDC. The pain has been going on since 06/2021 to present. There are times when resting, no sensational at all. But when raise arm, the pain threshold goes up quite a bit. On a pain scale it can go from 03/10 to a 7/10. 10/2021 Annual Physical; said I probably strained it. I thought it would go away and it has not.