chrisvoncsefalvay/vaers-outcomes huggingface dataset:
her tip of the head area to her ankles ( scalp, neck, torso) are all itchy, feels the need to itch; Delayed reaction; unusual fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (her tip of the head area to her ankles ( scalp, neck, torso) are all itchy, feels the need to itch), SKIN REACTION (Delayed reaction) and FATIGUE (unusual fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis. Concomitant products included IBANDRONATE SODIUM (BONIVA) from 06-Mar-2021 to an unknown date for Osteoporosis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced PRURITUS (her tip of the head area to her ankles ( scalp, neck, torso) are all itchy, feels the need to itch), SKIN REACTION (Delayed reaction) and FATIGUE (unusual fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (her tip of the head area to her ankles ( scalp, neck, torso) are all itchy, feels the need to itch), SKIN REACTION (Delayed reaction) and FATIGUE (unusual fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that next dose of ibandronate sodium for osteoporosis is due on 03-Apr-2021.
When I am starting the hives, I did not experience before, I thought it was mosquito bites, it was very itchy, I was scratching, it was race red welts. I looked at the mirror and I took Benadryl and other creams, nothing worked, it spread all over of my body, by next day I was in a discomfort, my throat was closing, I went to the ER, I did not get any treatment there, I gave up waiting and went home; and I was able to breath, but I could not swallow.  I did my own research about Hives; I went to the store and got a Xyzal (over the counter).  I took up to 15 mig I got a relief, in the meantime I saw a Dermatologist, and doctor said I was the 3rd person after Moderna booster with the same reaction and he had herself. Doctor said to continue taking medication as needed to control de hives.
pt recv vax 21AUG97 & 2SEP97 pt exp approx 20 lesions on all parts of body & presented to a clinic;
mental fogginess; balance issues; Dizziness; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anaemia. Concomitant products included LEVOTHYROXINE, VITAMIN D3 and VITAMIN B COMPLEX for an unknown indication.   On 21-Jan-2021 at 3:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues) and DIZZINESS (Dizziness). 22-Mar-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with MECLIZINE HCL from 23-Mar-2021 to 11-Apr-2021 for Vertigo, at a dose of 25 mg. At the time of the report, FEELING ABNORMAL (mental fogginess), VERTIGO (balance issues), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved.            The patient had cat scan of head and ultrasound of carotid artery. The patient was diagnosed with vertigo   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Added patient medical history Anemia , Added concomitant and treatment medications , Added event fatigue
Around 8pm started experiencing chills, coughing, shortness of breath. Had fever of 101 F, used VENTOLIN inhaler at hand and symptoms subsided.
COVID-19 resulting in inpatient hospitalization" of a vaccinated patient Pt received 2 doses of the Moderna vaccine but dates are unknown
This spontaneous report as received from medical assistant refers to an unspecified number of patients of unknown demographics. Medical history and concurrent conditions were not reported. On an unknown date, unspecified number of patients were vaccinated with PROQUAD (Merck) (dose, route of administration, anatomical location and lot# was unknown) which were stored improperly. Concomitant medications were unspecified by reporter. No adverse effects and product quality complaint was reported. The outcome of the events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information is not expected as reporter was not willing to be contacted.
Information was received from a consumer concerning her son who in 1996 and 2003 was vaccinated with a dose of Varicella virus vaccine live and has not seroconverted.  It was reported that she does not believe her son developed chicken pox.  Unspecified medical attention was sought.  No product quality complaint was involved.  No additional information was provided.  Additional information is not expected.
It was reported that a 16 month old female patient received a Tripedia vaccination on 09/24/01. On 09/28/01, the patient developed red spots on her chest that were flat, blanching, the size of pimples No treatment was given, patient was just monitored. The patient reportedly recovered from this experience.
Information has been received from the CDC concerning a 5 year old child with a history of asthma who was vaccinated with varicella virus vaccine live. the child was exposed to a classmate (WAES00120576) who had developed chickenpox. Subsequently the pt experienced chickenpox consisting of 100-250 lesions.  It was noted that the pt was not on any steroids at the time of his vaccination or at the time of the onset of his illness. Additional patients (WAES01034029,01034331) had a similar experience following exposure to varicella virus vaccine live.
Patient began having episodes of tachycardia and palpitations about 2 weeks after vaccination.  She reports increased palpitations with exertion or activity.  No chest pain. She does feel winded easily with activity.   She also reports abnormal uterine bleeding despite having the Nexplanon implant.  She has frequent menses with heavy bleeding.
Within 12 hours of immunization pt developed erythema, edematous rash in affected area. Rx antibiotics and antihistamine. Better.
02Mar, the night after vaccination, pt had right arm pain at the site of injection. On the following day, 03 Mar, pt noted arthralgias and fever to 101.3F that resolved with acetaminophen. No cutaneous findings.
Patient reported their arm being red; Patient who received this vaccine via subcutaneous route instaed of intramuscular; Administer higher dose than authorized; This spontaneous case was reported by a nurse and describes the occurrence of ERYTHEMA (Patient reported their arm being red), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 04-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) .5 milliliter. On 04-Apr-2022, the patient experienced ERYTHEMA (Patient reported their arm being red), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized). On 04-Apr-2022, ERYTHEMA (Patient reported their arm being red) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient who received this vaccine via subcutaneous route instaed of intramuscular) and ACCIDENTAL OVERDOSE (Administer higher dose than authorized) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Woke with some muscle aches that I didn?t think much of, but progressively worsened to the point where I didn?t want to leave my bed by the evening. Loss of appetite started around 4pm, despite being hungry. Fever of 102 began at about 1 or 2 pm and persisted until I went to sleep at 8 pm. I woke up with no fever the next day, but still experiencing body aches.
4/1/2022 at 2:00 eyes began itching and where becoming red and swollen. (left was worse than right). Swelling and redness where worse on 4/2. On 4/3 began experiencing extreme dizziness and vertigo. I was experiencing excessive sweats. Took OTC meds for vertigo. Drank cold water trying to cool off and ease vertigo. Became very nauseous and began vomiting. Laid down and took 3 hour nap. Vertigo was slightly better and no vomiting. Was able to get into see doctor and was advised to take Benadryl. Benadryl altered my sleep so I had to stop taking it. On 04/13/2022 vertigo and nausea have subsided. Eye irritation has improved.
pt was not well; her first dose of Shingrix on 15Aug2018 and her second dose on 16Mar2020; This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th August 2018).   On 16th March 2020, the patient received the 2nd dose of Shingrix. On 16th March 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her second dose late which led to lengthening of vaccination schedule.   Follow up report received from physician on 17th June 2020: The patient demographic details were updated. On 15th August 2018, the patient received 1st dose of Shingrix. On an unknown date, the patient experienced malaise after 1st dose of Shingrix. The patient was not feeling well when she was at nursing home. The patient received 2nd dose of Shingrix (batch number BF4J5, expiry date 5th July 2021) for prophylaxis.  The patient received 2nd dose outside the recommended 2 to 6 month window. The patient was not given 3rd dose. No follow up received from nursing home. It was unknown if the reporter considered the malaise to be related to Shingrix.
Patient received both vaccines on 5/31/19 and on this same day she was diagnosed with an ear infection. Vitals for this visit appear normal however i suspect that Patient may have also had a fever that was being controlled by Tylenol. I asked the provider if it was ok to vaccinate under current circumstances (i.e. ear infection) and she said it was fine.  Therefore Patient was vaccinated and later that day began a 10-day treatment of antibiotics.   -6/9 was her last day of antibiotics (Amoxicilan) and then on 6/10 is when we began to see hives around her torso which later spread everywhere (except inside mouth) and the rash became worse between 6/10 and 6/13 leading to 2 doctor's visits and 1 ER visit.  During this time (6/11-6/14) she also had a high fever 100 to 103 in spite of Tylenol  -The primary diagnosis was Erythema Multiforme
Gets black spots and it gets better. He states it is kind of bloody under there; broke out with red spots on quite a bit of his body; Did not take the follow up vaccination; This is a spontaneous report received from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (Pfizer vaccine, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On Unspecified date of Jun2021, the patient experienced that he gets black spots and it gets better. he states it is kind of bloody under there, broke out with red spots on quite a bit of his body, did not take the follow up vaccination. Patient did not received treatment for adverse events. Caller didn't provide his mail address and doesn't know whether his condition is serious or not. The outcome of the events was unknown.  Additional Context: Caller states he is calling about the vaccine, the COVID vaccine. Caller took the first dose of the vaccine on 20May, he states 2 weeks after he broke out with red spots on quite a bit of his body. His doctor said he should come in to let him look at it. He didn't know the regimen to do anything about it. He still has it though, it gets black spots and it gets better. He states it is kind of bloody under there. Caller states he did not take the follow up vaccination because his doctor recommended him not to. Caller is wondering if he should still have it. He is wondering if he should be able to take the other part of the vaccine. He does not know if he should do something about the spots. Caller states they have not really worsened. He states he does not have too much time, he could could call back at a different time to complete a safety report. The main question he is interested in is to know if doing nothing about these spots, is that alright. Are they going to go away, are they going to cause any damage. Rather than trying to figure out if he can receive the second shot or not. He guesses he has to do what the doctor says, he is seeing him again on the 7th. He didn't suggest putting anything on them and was not concerned what so ever. He does not know if it is ok for us to contact him should we have further questions about this report. He does go to a doctor and if its a controversy and this is something else. He doesn't want to be in a situation.  Information on the lot/batch, further information has been requested.
2 days, post vax, pt brought to clinic with complaint of headache, pain at site, chest pain and right hand/arm swollen.
Evening of 2/17/10 pt noted itching R arm, L breast. Noted welt on L breast. 2/18/20: itching only occ., no further welts. 2/18/10 pm itching waning but present.
Patient presented with shortness of breather, chest heaviness, & sore throat. Patient was taken to the ED for evaluation.
Pt had red, swollen, hot to touch site. Pt denied pain and was very active at follow ups. Pt was given Benadryl, Bactrim suspension 10cc po bid x 7 days and Prelone 15/5 5cc bidx 5 days.
On 8/5 the patient reported she didn't feel well after the vaccine, fatigue, arm pain, but was expecting this reaction because patient stated she had a similar reaction from the first Shingrix vaccine. Patient stated around 12:30am last night, she was very uncomfortable in bed, back/arm/leg pain, so she got up to sleep on the sofa, but before lying down she went to use the bathroom. Patient stated while she was in the bathroom she felt hot and got up to lie down and woke up lying on the floor and her husband was leaning over her. Patient stated, she has no injury, still has fatigue but feels much better. She refused a visit with the provider.
extreme muscle pain . it feels like a muscle tear and a sprain both at the same time . the severe pain that feels like a sprain comes and goes, but the sharp pain on the right side of my back is always there . also pain along my spinal column . . pain in lower left leg . pain on the front left side that feels like a stomach muscle . i don't know if this is muscle, ligament, or tendon . i have not been to the doctor about this . i have extreme social phobia and don't go out unless i absolutely have to . i didn't have pain in any of these places until i receive the vaccine . also, i had a bad reaction to the pneumonia vaccine which i received in November of 2020 and had bad lower back muscle pain, but that pain dissipated after a week or so . i told the doctor about the bad reaction to the pneumonia vaccine but she ignored me, so i didn't bother telling her about the Moderna vaccine problem . i was looking forward to being vaccinated, but i won't be getting the second shot now, because my body seems to not like it . it feels as though the vaccine is eating my muscles.
pt recv vax 26FEB96 & pt exp arthralgia & weakness of lt arm;arthralgia was described as a sharp pain & a palpation;pt recovered from the events in approx 3wk;
Heart pain/tightness similar to an episode of mitral valve prolapse however it occurred while sleeping and was severe enough to wake me up.   It occurred multiple times through the night of the first dose.  This has never happened before.
Patient had hives several hours after her first vaccination. They appeared on her right shoulder and upper back. She also had itching on her scalp. She experienced nausea for the first 12-24 hours.
Swelling at injection site, warmth, firm. Itching. No systemic symptoms. Started 2 hours after injection of booster dose.
First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved; First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved; First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 008B21A) for COVID-19 vaccination.     Previously administered products included for Flu: Flu Vaccine (IM Vaccine (right deltoid)) on 24-Oct-2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Blood pressure high (Started 25 years ago. She reported her HCP changed blood pressure medication a year ago.) and Thyroid disorder (Started 15 to 20 years ago).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved). At the time of the report, VACCINATION SITE ERYTHEMA (First primary series Moderna dose each time after the injection she experienced a red left arm that eventually resolved), VACCINATION SITE SWELLING (First primary series Moderna dose each time after the injection she experienced a swollen left arm that eventually resolved) and VACCINATION SITE PAIN (First primary series Moderna dose each time after the injection she experienced a sore left arm that eventually resolved) had resolved.            Concomitant medications was not provided by the reporter. Caller mentioned that she had lost a lot of weight over a year ago due to a healthcare after taking a beta blocker medication. She reported she had lost 145 lbs. Treatment information was not provided.   This case was linked to MOD-2022-577895, MOD-2022-577896, MOD-2022-577806 (Patient Link).
angioedema - swelling of upper lip; This is a spontaneous report from a contactable physician. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via intramuscular on 03Feb2021 12:00 at single dose in left arm for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM II), hypertension (HTN). No covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medication included lisinopril. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via intramuscular on 14Jan2021 12:00 at single dose in left arm for COVID-19 immunization. No other vaccine in four weeks. The patient experienced angioedema - swelling of upper lip on 05Feb2021 08:00.  The event was resulted in doctor or other healthcare professional office/clinic visit. Treatment included prednisone/diphenhydramine/Pepcid. The outcome of the event was recovered in Feb2021.; Sender's Comments: A causal relationship between BNT162B2 and the event angioedema cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .
Reporting administration error as per Agency. We contacted Pfizer for expiration dates. Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only include manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.
Left arm swelled, redness at the injection site and slight itching. Event happened the day after the injection which was on Saturday and was seen by MD.
PT RECEIVED FIRST PFIZER SHOT ON 7/7/21. RECEIVED SECOND PFIZER SHOT ON 7/21/21 (7 DAYS EARLY). PT MOTHER RECEIVED HER VACCINATIONS 2 WEEKS APART AND BROUGHT PT IN TO GET HERS IN THE SAME TIME FRAME.  WE REALIZED AFTER GIVING VACCINE THAT PT WAS 1 WEEK EARLY
had mild symptoms, not that severe effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had mild symptoms, not that severe effects) in a 74-year-old male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had mild symptoms, not that severe effects). At the time of the report, VACCINATION COMPLICATION (had mild symptoms, not that severe effects) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Additional information received captured reporter details.
Headache, dizziness, fatigue, nausea, body aches, chills all occurred on Friday May 7th. May 8th showed reduction in aches, chills, and fatigue, headache, dizziness and fatigue were intermittent throughout the day. May 9th (so far) has headache and dizziness.