chrisvoncsefalvay/vaers-outcomes huggingface dataset:
covid-19 virus test positive; A spontaneous report was received from a Consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 7 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Jan 2021, the patient experienced event- Tested positive for Covid.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tested positive for covid was not reported.; Reporter's Comments: Based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the event of tested positive for COVID and the product use is assessed as unlikely,
muscle aches; fever of 99.3; feeling very very sick; some weakness; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling very very sick), ASTHENIA (some weakness), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced MALAISE (feeling very very sick), ASTHENIA (some weakness), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever of 99.3). On an unknown date, the patient experienced MYALGIA (muscle aches). At the time of the report, MALAISE (feeling very very sick), ASTHENIA (some weakness), CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever of 99.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Body temperature: 99.3 (Inconclusive) 99.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by reporter. Treatment medication not reported. Action taken with mRNA-1273 was not applicable.
Patient had a syncope episode, felt tingly, dizzy, and clammy to the touch. Patient's blood pressure dropped to 98/62. Patient legs were elevated and a cold compress was used
FLU-LIKE SYMPTOMS; JOINT PAIN; HOT AND COLD SENSATIONS IN BODY; REAL HIGH FEVER/FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041S21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination at left deltoid. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced flu-like symptoms. On 31-MAR-2021, the subject experienced joint pain. On 31-MAR-2021, the subject experienced real high fever. On 31-MAR-2021, the subject experienced hot and cold sensations in body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from flu-like symptoms, joint pain, real high fever, and hot and cold sensations in body. This report was non-serious.
On May 30, I had diarrhea for no reason. On June 1, 2022 I thought I had allergies, I took my medicines including allergy medicines. As the day progressed a co-worker said she thought my voice sounded scratchy but I thought it was just allergies. Later in the day I sneezed and I was starting to think maybe I was positive so myself and my coworker took a home COVID-19 test. My test came back positive immediately, hers was negative, our boss sent us to the Health Department to confirm the test results. They did confirm that my results were positive. I went home to quarantine and noticed that my blood sugar levels were elevated. I called my doctor and I was told I could increase my Metformin to help keep my blood sugar levels down. On June 1 my blood sugar at 1:45am my blood sugar was elevated, woke me up because of tingling fingers. On June 2, 2022 I drank 194 ounces of water, 7:30am BS 185, 4pm BS 208, 8:30 BS 166 I have taken 1500mg of Metformin at this time. June 3, 2022, 6:15am 167BS fatigue loose bowel, at 11:00 BS 178, 9:45pm BS 144, 12:45am I wake up with anxiety so I take 2.5mg of Alprazolam, I wake up on June 4, 2022 at 4:30am BS160 I went back to sleep I woke up at 7:30am BS 138, at 12;30pm BS 133. My diet has been no carbs since June3. Slept great but lots of tingling. June 5, 2022 wake up at 6:30 BS 151, I woke up dizzy, 12;30 BS 214, 2:30PM BS 151, 8:45 BS 142. I'm feeling great it's just the tingling and the fatigue and sleeping 10 hours a night. I drank some vodka and ate sashimi the night of June 5, 2022 and woke up on June 6, 2022 BS 85, for dinner that night I drank vodka and ate poke' I wake up to BS 95. The next two nights I don't drink and BS goes up but the third night I drank and it drops.
Initial report received from a healthcare professional on 01 November 2013. A 84-year-old female patient who had unknown illness at the time of vaccination and no known allergies, had received an intramuscular first dose of FLUZONE HD vaccine (lot number: U4783AA, Expiry date: 06-JUN-2014) in the left arm on 28 October 2013. On 01 November 2013, the patient experienced 3 inches tender and black and blue area below the site of injection. Laboratory investigations and corrective medications were not reported. At the time of this report, the outcome was not reported. Documents held by sender: None. Additional information was received on 21 April 2014: No new information was received.
Began getting swelling/redness in left arm on 3/29/12 per parents. Pt was able to move arm & ambulate.
Information has been received from a physician concerning a female patient with aspirin allergy who on 17-APR-2007 was vaccinated with a first dose of Gardasil. On 17-APR-2007 the patient developed facial flushing with red cheeks and ears after receiving the injection. The patient was administered Benadryl and her symptoms resolved within 10 minutes. The patient was fully recovered. Additional information has been requested.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included a sterile diluent (manufacturer unknown). On 02-MAY-2018, the patient was inadvertently vaccinated with a properly stored but expired dose of VARIVAX lot # M019641, expiration date on 20-APR-2018 (administration route and anatomical location were not reported) for prophylaxis. It was confirmed that the vaccine was reconstituted with a properly stored sterile diluent (manufacturer unknown). No adverse reactions were reported.
Vaccine day-jan 8 ,21  arm felt heavy, next day small headache.  Jan 18,21 woke with round red , hot, hard and slightly raised area.  The area turned redder, hotter and bigger as days passed. Pain in arm and area of welt.  Jan 25 -21  area less red , same size and still warm. Tenderness on area and some heaviness  in arm but less.
I experienced soreness in my left arm, fever, chills, headache, difficulty breathing, fatigue and muscle aches.
Patient was in that day to receive his 11/12 y/o vaccines, after administering the Tdap and MCV4  to the Left arm, I then administered the HPV9 to the Right and immediately after I removed the needle and placed the Band-Aid on the injection site the patient laid back on the exam table, his grandmother and I had been joking with him previously because he had been questioning how bad all of his immunizations were going to hurt, so when he laid back we at first assumed he was being "dramatic" (grandmother's words) and she was talking to him and laughing, but when I looked at his face, eyes and color of his skin I knew he was not playing. Grandmother tried to sit him up right away but I asked her to please stop and step out of the way, I then removed the pillow from behind his head and laid him down flat and then elevated his feet. I got wet, cool towels to put on his face and the back of his neck. Within seconds the patient's color started to return to normal and the patient was questioning what had happened. I had him lay with his feet elevated for approximately 10-15 mins as we talked about what had happened, and it was then that he told me that he had not eaten anything all day because he had been busy. I then got him some cool water and some fruit snacks and a cheese stick, the patient sat up to eat and drink with no further problems. In total patient stayed in the clinic for about 30 mins post vasovagal syncope, and he and grandmother both left with no further complaints.
Information has been received from a nurse concerning a 14 year old male patient, who in approximately November 2010, "November or December timeframe", was vaccinated with a first dose of GARDASIL (Lot # not reported). The nurse reported that they were watching the patient and "10 or 15" minutes after vaccination, the patient passed out and fell and he happened to break his front tooth at the office. The patient was sent to see a dentist for his tooth. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient received vaccine on 11/9/21. The following morning on 11/10/21, the patient feels lethargic. Around 3pm, the patient experienced difficulty breathing and nausea/vomiting.  Her O2 saturation was around ~60% at 3pm. An hour later at 4pm, the patient's O2 saturation is ~92%.
Congestion in chest and sinuses, some swelling of throat and tongue.  Had taken Prednisone and Benadryl an hour before the injection.  Took an additional 25 mg. Benadryl about 90 minutes after the injection.   This was the second injection.  A worse reaction, with noticeable swelling of throat and tongue, as well as difficulty breathing, after the first injection on March 1.  Only Benadryl, and not Prednisone, was taken on that occasion.
Headache; Low grade fever; Nausea; Diarrhea; Sore injection site; Dose 1 administration date:21Jan2021/ Dose 2 administration date:04Feb2021.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL3248), via an unspecified route of administration on right arm on 04Feb2021 at 14:00 (at the age of 28years) at single dose for covid-19 immunization. Medical history included asthma. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and an unspecified multivitamin which were received within 2 weeks. Historical vaccine included first dose of bnt162b2 (lot: EL3248) on left arm on 21Jan2021 at 16:30 (at the age of 28years) for COVID-19 immunization. On 05Feb2021 at 12:00, the patient experienced headache, low grade fever, nausea, diarrhea, and sore injection site. No treatment was received for the adverse event. The events were considered by the patient as non-serious as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no Congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered at the workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events headache, pyrexia, nausea, diarrhoea and vaccination site pain was recovered in Feb2021.
Chest pain dull in nature and constant without dyspnea, nausea, vomiting
Post vax, the patient developed varicella. Unspecified medical attention was sought. The patient's brother and sister had similar experiences following exposure to varicella virus vaccine. Additional information has been requested.
Temperature of 101.4; This case was reported by a consumer via (Shingrix interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received 2nd dose of Shingrix and experienced temperature of 101.4 Fahrenheit. The patient asked whether it's normal reaction to vaccine or not. No further information reported.
dysequilibrium beginning approx 60hours after the 2nd covid-19) and lasting 12-15 hours No vertigo or lightheadedness Complete resolution after 12-15 hours
This spontaneous report was received from a patient's father and refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 16-NOV-2017, the patient was vaccinated with unidentified Merck HPV vaccine (name and lot number not provided) for cyst, not for prevention of HPV. The patient had scheduled vaccination with second dose of the vaccine on 08-FEB-2018. No adverse effects were reported.
Patient reports onset of flank pain (he describes as "pain in his kidneys") one day post-vaccination. He states that he went to the emergency room and the doctors were not able to diagnose the cause of the pain. The next day the pain continued and he has developed shingles on his side.
On Day 8, woke up with sore arm. Became red, hot, swollen in area from just below shoulder to just above elbow. Using ice and ibuprofen,  but still swollen and sore on day 10.
This spontaneous report was received from a registered nurse and refers to a 6-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 19-DEC-2016, the patient received a dose of ROTATEQ (orally, dose, lot# and expiration date were not provided), which was outside of the recommendations in the ROTATEQ prescribing information. No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Patient reports continuing pain at the injection site 16 days after vaccination. Denies redness, itching or lump.
Cough, shortness of breath, tachycardia. Transported to ER. Tryptase drawn - 4.6. Symptoms resolved with benadryl
Headache, Myalgia, Fever, Diarrhea, INJECTION SITE PAIN Narrative:  Other Relevant History:
Pneumonia; Falls; wasn't moving around; weak; sick; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; tested positive for COVID-19 on 27AUG2021, after receiving both doses of BNT162B2; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program and Medical information team. A 91 years old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE at the age of 90 years old and via an unspecified route of administration on 05Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE at the age of 90 years old for COVID-19 immunization in a retirement facility. Medical history included ongoing Parkinson's disease and ongoing dementia. The patient's concomitant medications were not reported. The patient was just getting over COVID-19 and pneumonia and he is on antibiotics and a blood thinner. The patient is very weak because he wasn't moving around a lot when he was sick so he is doing physical therapy. Reported treatment for events was antibiotics and blood thinners, Mucinex, Inhalers and physical therapy. The patient has been to the ER for falls and he fell again last week. Caller states they didn't keep him overnight, they just checked him in the ER. The patient was under the care now in the community retirement facility they live in. The patient tested positive for COVID-19 and developed pneumonia by late Aug2021. The patient tested positive for COVID-19 on 27Aug2021, after receiving both doses of BNT162B2. The fall resulted in emergency room and all the events resulted in physician office visit. The outcome of COVID-19 was recovered on 11Sep2021, pneumonia and fall recovered on unspecified date. The outcome of the rest of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Per Dr's notes: "Pt rec'd a zoster vaccination on 6/20/07. The following day she noticed some dysesthesia at the arm, the day after that she noted some redness of the injection site and over the next few days there has been and continued dysesinesia on the general upper arm on the outer aspect and a gradual increase in the amount of rash noted. Exam confirm a papular rash generally distal to the injection site from the mid right deltoid down to the elbow w/some spots in the antecubital fossa."
Extreme vertigo, nausea, fatigue. Vertigo was extreme for a week and then occasional for next 3 months.
bilateral elbow pain and redness, rash on face, neck, hands, thighs and feet treated with benadryl, famotidine, and prednisone
Severe diffuse hives with minimal lip swelling developed 8 days after vaccination. Improvement with benadryl however required ongoing dosing every 6 hours with recurrence and relief of symptoms. Started on zyrtec and prednisolone. Ongoing symptoms at time of report
Vaccine given 5 days to early. Outside of grace period. Called patient and told him to get re-vaccinated,
loss of smell, sinus congestion, eye watering. starting on 11/26/21
t101.0 ax 25OCT96 PM;t102.9 26OCT96AM;crying not consoled by APAP;tepid baths do not dec temp;temp responds to Ibuprofen & pt ceases crying 10-15min,  but remains tearful throughout weekend;seen by MD 28OCT96 AM dx w/acute ear infect
Patient had her 1st dose of the vaccine on Friday 8/20. Over the next day the patient developed nausea, vomiting and abdominal pain. The pain continued until the patient presented to the emergency department on 08/22. Patient was found to have emphysematous gastritis. She was started on antibiotics and admitted to the intensive care unit. The patient also had significant elevation in liver enzymes. She developed altered mental status and eventually respiratory failure and was unable to protect her airway. Further radiologic examinations showed perforated viscus and diffuse pneumoperitoneum. Patient died on 08/24.
sore arms; stiff neck; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's relative). A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had sore arms and had a stiff neck after the first dose. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of (Oka/Merck) VARIVAX (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperature outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
1 week after receiving the vaccine she developed a large hive to the injection site and she has developed a few small additional hives to her left upper chest the past week.  Areas of hives are mildly itchy. She states she is very nervous about this and thinks that her anxiety has contributed to making her feel intermittent mild shortness of breath and yesterday she had a mild right-sided headache & 1 episode of diarrhea that resolved.  She received to the vaccine at clinic. She has an allergy to sulfa drugs that gives her hives.  She reviewed the ingredients in the Moderna vaccine and it does not seem to contain any sulfa.  She has not taken any medications for these symptoms.
Right armpit tender and swollen lymph nodes noted the next morning (01/10/2021) after 2nd IM injection administered.  Fatigue and headache occurred by the same afternoon and low grade fever of 99.6° that evening at 8:30 PM.  Right armpit tender and swollen lymph nodes remain present 2 days post 2nd IM injection and right arm injection site is warm to touch with redness and firmness to touch.
Within 15-20 min left arm, side of face, left leg numb. Of course site (left) discomfort. Numbness gone by next morning. Site pain which has continued - still feels sore as when received shot, shoulder pain-joint can still feel where needle went in.
Information has been received from a medical assistant referring to a 16 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 02-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K016153 with expiration date 24-SEP-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 4/22/21 lot# 007C;  Moderna 5/20/21 lot# 037C21A
Aches and pains; Nausea; Lymph node swelling; This is a spontaneous report from a contactable consumer (patient's child). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After the second dose, the patient experienced aches, pains, nausea, and lymph node swelling on an unspecified date after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276515 Same reporter, product, and event; different patient
The evening of the day dose was administered pt experienced sweats, fever, difficulty breathing and racing heart. She self treated with Benadryl and symptoms resolved that night.
Pt became mostly  unconscious/unresponsive for approximately 24 hours after vaccine and very pale. Hospice nurse called to facility. Pt vital signs stable and pt on hospice, so family did not elect to go to hospital. Pt did eventually start arousing the next day but was lethargic . Pt started eating and drinking normally after approximately 2 days.
dizziness & nausea began p/working on computer afternoon p/vax;has tendency toward dizziness;