chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent headache; Soreness at injection site several days post-vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732), via an unspecified route of administration on an unknown date at 10:00 as a single dose for COVID-19 immunisation. Medical history was not reported and the patient had a history of allergy to ceclor and sulfa. Concomitant medications included ethinylestradiol; ferrous fumarate; norethisterone acetate (LOESTRIN-FE) from an unknown date for an unknown indication. The patient previously took cefaclor (CECLOR) on an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced persistent headache and soreness at injection site several days post-vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events persistent headache and soreness at injection site several days post-vaccine was not recovered at the time of this report.    No follow-up attempts are possible. No further information is expected.
Immediate pain in left deltoid, with swelling beginning. Two hours later onset of extreme dizziness and nausea and lightheaded. Unable to stand up due to dizziness. Headache lasted more than three days, also stomach ache. Next day developed sore lips, blisters on tongue and roof of mouth. It is now one week after injection, arm pain and swelling is gone. Still have slight headache. Still have sore lips, tongue and mouth. Stomach feels like gastritis (which I once had after taking flagyl p.o.). I have felt extremely tired all week, had to lay down during the day, which I never do.
This spontaneous report was received from a friend of patient's parent referring to a child patient of unknown age and gender. The patient pertinent medical history and concurrent condition were not provided; concomitant medications were unknown by reporter. On an unknown date, the patient was vaccinated with GARDASIL for prophylaxis (strength, dose, route, Lot # and expiration date were not reported). When the reporter mentioned to their friends that decided to vaccinate their child, one of them told them how their child had an unspecified bad reaction to GARDASIL (adverse reaction) on an unknown date. It was unknown if any laboratory test was performed. The reporter was shocked and sad that the patient had to go throught that, however, they decided to vaccinnate their child with the GARDASIL after read stories; pharmaceutical pamphlets and understood the pros and cons to the vaccine. After hear the story, they still made the decision to go forward in spite of the risk as was better than to get a Human Papillomavirus Infection. At the reporting time, the outcome of the adverse reaction was unknown. The reporter considered the adverse reaction to be related to GARDASIL.
patient reported to have itching, swelling and redness at the site of injection for couple of days. Patient also got flu like symptoms, nausea and GI issues for 5 days after vaccination. Patient is better now
Received my vaccine on December 22nd, 2020 at around 830 Am. That afternoon, about 3 PM, I started to have a reaction. It started with tingling/numbness in my right hand which progressed up my arm into my elbow. About 10 minutes later, it then progressed into my right foot, and my left foot. About 10 minutes after that, I started to get flushed and a neck rash (diagnosed from Dr.). I took Benadryl and Ibuprofen 800mg PO every 6 hours for the next 24 hours. The numbness in my right foot and left foot along with the flushness went away a couple hours later. Although, the numbness in my right hand never went away. It came and went for the next 4 days until December 27th and 28th when it started getting worse. On December 28th evening, it got so bad that I was debating going to the emergency room around 1 am. The numbness and tingling was in my right hand and started shooting up my arm. The nerve pain around my wrist was unbearable. I finally fell asleep and the next morning, it was not nearly as bad, but was still there.  The numbness and tingling moved from my right hand mainly to right hand, right foot, right leg, left foot and left hand today (12-30-2020).
diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by Rapid Test; diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by Rapid Test; She is still sick; This is a spontaneous report from a contactable consumer or other non hcp. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955; Expiration Date: 30Jun2021) intramuscular on 21Apr2021 (at the age of 43-years-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955; Expiration Date: 30Jun2021) intramuscular on 31Mar2021 (at the age of 43-years-old) as dose 1, single for COVID-19 immunization. Investigation assessment was performed. No other vaccination within 4 weeks prior to the first administration of the vaccine. On an unspecified date, she is still sick, diagnosed with COVID/not only by PCR sent out to lab but I also confirmed it again by rapid test and vaccination failure. The patient underwent lab tests and procedures on an unspecified date which included polymerase chain reaction positive on tested by LABCORP, SARS-CoV-2 test: positive on tested by LABCORP. The patient was not taking any other treatment medications. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Shot given 3:30A. 30 min. after receiving the flu shot, arm red and very swollen and vomited x 2. Arm had a "throbbing sensation." Arm was warm to the touch. Noted on 9-30-11 7A: >6cm, diameter redness on left deltoid. Advised to see her primary MD. Itching noted on 9-30-11 - 2pm.
fever; tired; slight headache; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A 58-year-old non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: not reported, Expiry date: not reported) via an unspecified route of administration on 14Mar2021 10:00 (at the age of 58-years-old) as DOSE 1, SINGLE for covid-19 immunization. Patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Unknown if the patient had known allergies and other medical history. Unknown if the patient received other vaccine in four weeks. The concomitant (other medications in two weeks: unspecified) was reported. On 14Mar2021, the patient experienced fever, tired and slight headache. The patient did not receive any treatment for the events. Outcome of the events was recovering.   No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained. No further information is expected.
I received my second Moderna  booster for COVID-19 on 4/15/2022. On 6/29/2022, I woke up with the sniffles. I then took a home test for COVID-19, and I saw a faint pink line indicating a positive result. That evening, I had a headache concentrated around my eyes, which is unusual for me, since I'm not given to having headaches. I took some Tylenol for the headache, and it helped relieve it. I felt that there was definitely something off, though. On the morning of 6/30/2022, I tested myself again, and I again got a positive result. On 6/30/2022, I got a prescription for a 5-day course of Paxlovid. On 7/2/2022, I tested myself again, and I got another positive result. When I tested myself again on 7/3/2022, I got yet another positive result. During the times that I was testing myself, I had few symptoms. Other than a mild case of the sniffles, I felt fine. On 7/5/2022, I took another home test, and I finally got a negative result. I took more tests subsequently to make sure that I was really COVID-free, and they all yielded a negative result.
patient was given IPOL that was exposed to temperature excursion and is no longer suitable for use with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient to whom administered Ipv (Vero) [Ipol] that was exposed to temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Aug-2023, the patient received a dose 2 at a dose of 0.5 ml of suspect IPV (VERO) (frequency: once, strength: standard, expiry date: unknown and lot W1A191M) via subcutaneous route in the right arm for immunization (poor quality product administered) (latency: same day).  It was reported that" caller asks if they should re-vaccinate the patients after being given IPOL that was exposed to temperature excursion and is no longer suitable for use."  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.; Sender's Comments:  US-SA-2023SA256871:01733160
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: 1808609 and expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced chest tightness. On APR-2021, the subject experienced muscle pain in butt. On APR-2021, the subject experienced overly tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest tightness, muscle pain in butt, and overly tired. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
diarrhea; still achy; felt like ball of smthing in skin; has a hole in her arm / where the shot was given; injection site was swollen / felt like a ball of something was in her skin; injection site was swollen Saturday, extremely hot; could not sleep on right side / was up from 9pm to 6 am Sunday; very edgy and depressed; This case was reported by a consumer via call center representative and described the occurrence of injection site injury in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th March 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th March 2021, less than a day after receiving Shingrix, the patient experienced injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, pain and swelling. On 28th March 2021 10:00, the patient experienced diarrhea. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site injury, injection site warmth, pain and swelling were not recovered/not resolved and the outcome of the injection site swelling, sleep disturbance and diarrhea were recovered/resolved and the outcome of the tension was unknown.   It was unknown if the reporter considered the injection site injury, injection site swelling, injection site warmth, sleep disturbance, tension, diarrhea, pain and swelling to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient herself. The patient got her first shingrix shot in her right arm. The patient stated that she still had a hole in her arm where the shot was given. She stated that the injection site was swollen, extremely hot, felt like a ball of something was in her skin, and she could not sleep on right side and was up from 9 pm to 6 am on 28th March 2021. The patient was very edgy and depressed. On 28th March 2021 at 10 am in morning, she had diarrhea, which was very unusual for her, she was still achy.  On 29th March 2021, the patient went to work, took some benadryl and the swelling went down. The reporter consented to follow up. Later, the patient called to provide her healthcare professional's information.
4-6-22 I had experienced palpitation and I used a cardia mobile heart monitor which told me I was experiencing AFIB with a rapid heart beat, 138. On 4/7/2022 went to the ER. I had a chest x-ray and blood work. On 4/8/2022 I went to a Cardiologist and am wearing a heart monitor I had another event last night.
Hair loss/hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss/hair falling out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 17-Apr-2021, the patient experienced ALOPECIA (Hair loss/hair falling out). At the time of the report, ALOPECIA (Hair loss/hair falling out) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains non-significant information including patient's withdrawal of consent for follow up and updated event verbatim
Arm pain causing lack of sleep; Arm pain causing lack of sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep) in a 6-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep). At the time of the report, PAIN IN EXTREMITY (Arm pain causing lack of sleep) and SLEEP DEFICIT (Arm pain causing lack of sleep) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant and treatment medications were not reported.  Reported that patient had arm pain causing lack of sleep and needing to stay home from school.
I26.99 ACUTE PULMONARY EMBOLISM 3/29/2023 HYPERCHOLESTEROLEMIA I82.409 ACUTE DVT, UNSPECIFIED VEIN 4/28/2023 HYPERCHOLESTEROLEMIA
I was menstruating at the time of the vaccine, beginning on April 2. I am still menstruating today, April 27, without ceasing. Beginning April 10, I began menstruating extremely heavy, with very large clots. I am under a physicians care and being tested for anemia and have an ultrasound scheduled as well.
Pt describes getting a fever blister in her nose about 2 weeks after the vaccine, then after that resolved, she immediately had a fever blister appear just outside her nostril at the base of the nose, and just after that resolved, she now has a fever blister that has appeared on her lip.
Approximately 6 hours and 30 minutes after vaccination, patient became slightly dizzy and nauseous, and went to bed. The morning after, the patient had body aches and a headache, and took 500mg of acetaminophen at approximately 5am.  The patient also noticed swelling at the injection site (raised and approx 5 inches in diameter) and itching at this time as well. The patient took another 500mg of acetaminophen at 2pm, 200mg of ibuprofen at 3pm, and complained of a sensation of hypersensitivity and mild "burning" across the skin. These symptoms subsided by about 5pm, and patient felt well enough to stand up and have a small meal before returning to bed. At that point (~5pm), they developed a low fever (temp fluctuated between 99.5-100.6F), and took 400mg of ibuprofen and another 500mg of acetaminophen, and their temperature reduced to 98.6 at approximately 8PM. Afterwards, the patient had fatigue and some aches, and the swollen arm has not subsided at the time of report entry (~42 hours after vaccination).
This spontaneous report was received from a nurse practitioner and a registered nurse, for GARDASIL, a pregnancy registry product, concerning a 24 year old female patient allergic to latex and cats, with drug hypersensitivity to OMNICEF and no pertinent medical history who on 01-NOV-2011, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL, (lot number and expiration date not reported) and on 06-MAR-2012 was vaccinated intramuscularly with the second dose 0.5 ml dose of GARDASIL, (lot number 1490AA, expiration date 15-AUG-2014). There was no concomitant therapy. On 06-MAR-2012, the patient had a negative urine pregnancy test. At some unspecified point after the second dose, the patient had sexual intercourse and the condom broke. The patient took PLAN B. Then on an unspecified date the patient had two negative and one positive urine pregnancy test. On 27-MAR-2012, the patient went to the physician's office and a urine pregnancy test confirmed pregnancy. The patient's last menstrual period was on 15-FEB-2012, the EDD was approximately 21-NOV-2012. The patient was given prenatal vitamins (manufacturer unknown). At the time of the report the patient was still pregnant. Follow up information has been received from the nurse practitioner. The reporter stated that a baby was born without incident on 04-AUG-2013. There was no mention in chart of any congenital anomalies and no complications during pregnancy. The baby was male and APGAR scores were 8 and then on second check 9. The birth weight was not available and there was no mention if the patient ever finished her GARDASIL series. There was no information pertaining to a consent form signed by mother for infant's pediatrician. Additional information has been requested.
Pt had 4th DTaP administered on 9/5/13. Woke with fever 9/6/13. Tmax 104-105. Eval in office, temp 101.3, exam.
I started having intermittent numbness, tingling, pain and weakness in my left arm down to my hand about a week after my second Pfizer Covid vaccination. Over several months it progressively was getting worse. I am a nurse in a hospital and after speaking with several colleagues (other nurses and doctors) about what was going on, I went to my PCP. After seeing my PCP, I was referred to a Hand to Shoulder Center. The doctor declared it as cubital tunnel syndrome in which I had an Ulnar Nerve Release Surgery on June 8th. Approximately a week and a half to two weeks after the surgery I started noticing intermittent numbness and tingling to the left side of my lips and left side of my face. Until I started having issues with my face, I didn't even consider the possible correlation with my problems and the COVID vaccines. It it just ironic that I received both vaccines in my left arm and I am having issues with my left arm and the left side of my face. I am still having numbness, tingling and some weakness to my left arm as well as the intermittent numbness and tingling to the left side of my face. Now I was advised by the surgeon that it could take up to a couple of months for my issues with my arm to resolve but when I contacted my PCP regarding an update on my arm as well as to inform her about the concerns with my face, and questioning the possible correlation with the COVID vaccines, she advised me to file a report through VAERS.
Patient experienced total body ache and headache, patient was recommended with Tylenol or Motrin for the pain/headache, follow-up with prescriber recommended
Right armpit became very sore and swollen about the second day after vaccine.  It took a week or more for this reaction to go away.
This spontaneous report as received from a pharmacist refers to a 24 year old female patient. The patient's medical history included birth of her child (date not specified). In 1991, exact date not specified, the patient was vaccinated with the first dose of M-M-R II. On an unknown date, the patient received the second dose of M-M-R II. On 09-SEP-2014, the patient was vaccinated with the third dose of M-M-R II (HSA) lot number J004204, expiration date 12-APR-2015, 0.5 ml, subcutaneous in the left arm, which was improperly stored. No adverse effects were reported. Concomitant medications were not specified. Additional information is not expected because the reporter did not give consent for follow up.
This spontaneous report as received from a nurse refers to a 6 month old patient of an unknown gender. On 29-JAN-2015, the patient was vaccinated with improperly stored ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
On day 11 post vaccine administration, I started to experience an irregular heart rhythm.  I went to the ED at my place of employment and was found to be in atrial flutter.  Just prior to them administering a medication (metropolol), I spontaneously converted back to sinus rhythm.  I was sent home and told to follow up with my PCP or go to the ED should it return.   The following evening around 515 pm, I went into the same type of rhythm so went to the ED for evaluation.  I was again found to be in atrial flutter after a repeat EKG was done.  About two hours after arriving, I was cardioverted and my rhythm returned to sinus rhythm. I was discharged home and continue to be in sinus rhythm and am now on blood thinners.
Had VARIVAX 4-14-07 in another country & now developing varicella.
Starting about 1 week after receiving the vaccine, I started noticing a slight rash on my feet and hands, and it slowly began spreading to all of my extremities. I took some OTC Benadryl to see if that would help but it didn't seem to do anything. I had gone to urgent care after work because I was concerned that this was more than just a rash. However, they determined it was just a reaction to the vaccine. They gave me a steroid injection and a more powerful Benadryl to calm it down which helped. It lasted for about 1.5 - 2 weeks then calmed down. I had no other symptoms other than itching.
Pain, numbness, tingling down left arm that started 10 minutes later, weakness in left 4th and 5th fingers that is still present. Tx: Ibuprofen (OTC), cold locally.
Pt. c/o pulled muscle in (R) lower leg x 3 since receiving vaccinations on 3/13/12. Pt. states she was told by her private MD that vaccines can cause muscle tears (??). Pt referred to ortho specialist for further evaluation.