chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Warmth; diarrhea; lethargic; itchy hives from left neck to shoulder to elbow; itchy hives from left neck to shoulder to elbow; headaches; nauseous; difficulty sleeping, had to sleep with pillow under arm; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (injection arm soreness), INSOMNIA (difficulty sleeping, had to sleep with pillow under arm), VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea) and LETHARGY (lethargic) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (injection arm soreness). On 13-Mar-2021, the patient experienced INSOMNIA (difficulty sleeping, had to sleep with pillow under arm). On 14-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea), LETHARGY (lethargic), VACCINATION SITE PRURITUS (itchy hives from left neck to shoulder to elbow), VACCINATION SITE URTICARIA (itchy hives from left neck to shoulder to elbow), HEADACHE (headaches) and NAUSEA (nauseous). At the time of the report, PAIN IN EXTREMITY (injection arm soreness), INSOMNIA (difficulty sleeping, had to sleep with pillow under arm), VACCINATION SITE WARMTH (Warmth), DIARRHOEA (diarrhea), LETHARGY (lethargic), VACCINATION SITE PRURITUS (itchy hives from left neck to shoulder to elbow), VACCINATION SITE URTICARIA (itchy hives from left neck to shoulder to elbow), HEADACHE (headaches) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received form an unknown reporter referring to unknown number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On unknown dates, unknown number of patients were probably vaccinated with improperly stored doses of GARDASIL 9 (lot# and expiration date not specified; dose, route, site of administration unknown) for prophylaxis. It was reported that GARDASIL 9 lot # L000610 (expiration date 31-JAN-2017), lot # reported as L031429 (expiration date 21-JUL-2017), L025737 (expiration date 28-JUL-2017) and L016428 (expiration date 30-JUL-2017) underwent a temperature excursion in 2015. From May 2015 to December 2015, the minimal/maximal temperature was 33/46, 32/46, 32/ 47, 31/48, 32/47, 32/48, 32/48 and 31/56 (units not provided) respectively. The lot number L016428 (expiration date 30-JUL-2017), L019297 (expiration date 18-AUG-2017), L044475 (expiration date 12-MAY-2017), M005714 (expiration date 03-OCT-2017), M011117 (expiration date 07-DEC-2017), M009378 (expiration date not provided), M026306 (expiration date 30-APR-2018) and M017983 (expiration date 30-MAY-2018) underwent a temperature excursion in 2016. In January to September, November and December of 2016, the minimal/maximal temperature was 31/49, 31/49, 30/ 86, 31/75, 30/49, 27/86, 29/86, 26/51, 28/54, 24/49 and 24/53 (units not provided) respectively. There was no GARDASIL 9 lot number reported in 2017 temperature excursions.  This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA007740: US-009507513-1705USA007741: US-009507513-1705USA004287: Original Case : 1705USA004287 US-009507513-1706USA001287: US-009507513-1706USA001288: US-009507513-1706USA001289: US-009507513-1706USA001290: US-009507513-1706USA001291:
AROUND 1 PM PATIENT START ITCHING AT THE POINT OF INJECTION AND THEN IT SWALLOW AND FELT WARM PATIENT TOOK IBUPROFEN 200 MG ONCE A DAY FOR 3 DAY AND ALL SYMPTOMS DISAPEARED ON TUESDAY 09/21/2021
On 2/1/17 we noticed a 1 1/2 inch bald spot on the back of her head. Started complaining of tingling in her hands and feet and chest pains. 05/17 started complaining of extreme fatigue and started with a cough. Went to pediatrician in June and they noticed her BP was high and sent us to ER they treated her with an IV and sent us home. 07/17 started to get rashes from the sun and hot water, felt nausea, had stomach pain, her feet and hands started turning purple, lost weight, could not eat, got heart palpitations, felt dizzy and everything would get black and she almost passed out.
Pain in upper arm distribution, burning & numbness began 24 hours after injection. No redness, induration or temp noted. Unresponsive 2 weeks. Naprosyn 500 twice a day. No motor signs.
Pt given incorrect vaccine. Wanted BOOSTRIX and was administered FLUVIRIN PF.
I experienced major adverse side effects from the 3 Pfizer vaccines for Covid-19. I had an area of numbness in my mid-back after the first 2 Pfizer vaccines (1st dose: 3/23/21 - 2nd dose: 4/20/21). My PCP advised that other patients experienced numbing, but benefit outweighs the risk. Proceeded with the Pfizer Booster on 12/18/21. On 12/22/21, I was driving my car with my husband and 9 year old son looking at Xmas lights. I felt a zap in my head, then fell slowly unconscious. I woke up in a full sweat, then had a loss of bowel. The next day, I started to notice circulation issues and my hands were turning bright red, then white within seconds. It continued to happen days following. The following 2-3 weeks, I had sudden weight loss (8-9 pounds) with severe muscle atrophy, Inflammation of the small and medium blood vessels (Rhuematologist), Raynaud's Syndrome in hands/feet, hair loss, overactive bladder, blood clot as large as a golf ball, followed by period abruptly stopping for 5 months (had hormones checked a month prior and still had good hormone levels and follicles) , full pelvic prolapse & ongoing stiff torso that has lasted now for 10 months and has not gotten better.
It swelled up like a baloon; Couldn't stand; Abdominal pain; Couldn't sleep; Dizziness; A 104F-plus fever; Nausea; Had a sore right arm; Vomiting; Had a headache that was so bad she thought she was going to stroke out; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (It swelled up like a baloon), MOBILITY DECREASED (Couldn't stand), ABDOMINAL PAIN (Abdominal pain), INSOMNIA (Couldn't sleep) and DIZZINESS (Dizziness) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's thyroiditis.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced SWELLING (It swelled up like a baloon), MOBILITY DECREASED (Couldn't stand), ABDOMINAL PAIN (Abdominal pain), INSOMNIA (Couldn't sleep), DIZZINESS (Dizziness), PYREXIA (A 104F-plus fever), NAUSEA (Nausea), VACCINATION SITE PAIN (Had a sore right arm), VOMITING (Vomiting) and HEADACHE (Had a headache that was so bad she thought she was going to stroke out). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, SWELLING (It swelled up like a baloon), MOBILITY DECREASED (Couldn't stand), ABDOMINAL PAIN (Abdominal pain), INSOMNIA (Couldn't sleep), DIZZINESS (Dizziness), PYREXIA (A 104F-plus fever), NAUSEA (Nausea), VACCINATION SITE PAIN (Had a sore right arm), VOMITING (Vomiting) and HEADACHE (Had a headache that was so bad she thought she was going to stroke out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 13Dec2019 after being on vacation patient ended up in hospital with flu like symptoms, pneumonia, thyroid toxicosis, & an elevated heart rate of 100 to 120   This case was linked to MOD-2021-406574, MOD-2021-406622, MOD-2021-406763 (Patient Link).
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to a 11 years old patient of an unknown gender. The patient's medical history and concurrent conditions were not reported. On 26-MAY-2015, the patient was vaccinated with a dose of VAQTA (lot # K007791, expiration date 22-AUG-2016, dose, frequency and route of administration were not reported), which was exposed to temperatures outside of the recommended range. No adverse effect was observed or reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Diarrhea, Chills, pain swelling at injection site Narrative:
This spontaneous report as received from a licensed practical nurse refers to the three patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD injection (lot # M021428 with expiry date on 19-OCT-2017, albumin status: recombinant human albumin (rHA); dose was not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1612USA008584: US-009507513-1610USA010040.
Patient received all 2 month vaccinations as IM injections instead of receiving the Rotarix as an oral vaccine.  The patient did not experience any adverse events.
Back is in so much pain; Takes his breath away; Dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back is in so much pain), DYSPNOEA (Takes his breath away) and DEHYDRATION (Dehydrated) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced BACK PAIN (Back is in so much pain), DYSPNOEA (Takes his breath away) and DEHYDRATION (Dehydrated). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back is in so much pain), DYSPNOEA (Takes his breath away) and DEHYDRATION (Dehydrated) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Fever, tremors.  Woke up at 2 A on 7-2-10 with fever, 102 and full body tremors.  Taken to hosp ER.  Chem 7 done, WNL.  F/u in our office 3P today.  Afebrile in office.
Body aches, sore arm, chills, feeling hot  Treated with Tylenol
At the injection site: raised red welt, very painful and hot to the touch. Welt went away after 3 days and then the injection site became very itchy for several more days. Exactly 2 weeks after the vaccine injection, the welt came back. It was about 2? in diameter. Again, the site was red, raised, itchy, and hot to the touch. My arm felt weak. The welt went away within 24 hrs.  Arm remained itchy for 48 hrs
Red Rash, burning, blistering and skin peeling. Symptoms returned 11/16/2020 Red Rash, burning, blistering and skin peeling. Patient had flu vaccine same day, intramuscular on L side. Flu vaccine type give unknown.
swollen and tender RT upper  arm that progressively worsened distally. + some itching. Was treated preemptively on 5/26/20 per telemedicine encounter as cellulitis w/ PO keflex + prednisone, after 1 dose of keflex patient's swelling and tenderness reduced. Was seen in office on 5/27/20.
Rash & itching devel on trunk only @ 1 1/2 hrs p/vax; reports anxiety-like feeling just prior to onset of rash; later in day devel swollen cervical nodes, generalized aching, sore neck on 1 side; trunk feels scaly;
Severe hives on shoulder that received shot, neck and face; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on 15Apr2021 at 09:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included gliclazide (CLARITIN), triamcinolone acetonide (NASACORT) and omeprazole (PRILOSEC) for an unknown indication from an unknown date and unknown if ongoing. On 15Apr2021 at 20:30, the patient experienced severe hives on shoulder that received shot, neck and face. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe hives on shoulder that received shot, neck and face was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Shortness of breath , extreme pain 3 hospital visits until blood clot was detected,now on blood thinner Eliquis
This spontaneous report was received from a physician referring to an unknown number of patients of unknown gender and age. Pertinent medical history or concurrent conditions were not reported. Since 30-MAY-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB which had the lot # reported as N00236, expiration date 24-OCT-2019, lot # N000235, expiration date 26-OCT-2019, lot # N003536, expiration date 02-NOV-2019, for prophylaxis (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32 degrees Fahrenheit and the highest was 54 degrees Fahrenheit for 49 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow-up information has been received from a physician on 16-OCT-2017 to an unknown number of patients of unknown gender and age. The patients' concomitant medications, pertinent medical history, drug reactions or allergies were not reported. Since 29-APR-2017 (also reported as since 10-APR-2017), the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # M046140, expiration date 27-SEP-2019, dosage information and route were not provided) for prophylaxis. Additionally, it was reported that the lowest temperature was 47 degrees Fahrenheit and the highest was 49 degrees Fahrenheit for 16 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. Follow up was received from the physician on 30-OCT-2017, regarding a 16-month-old patient, who on 15-JUL-2017, received a dose of improperly stored PEDVAXHIB injection, lot # N000235 with expiration date on 26-OCT-2019. The vaccine underwent temperature excursion of 34-49 degrees Fahrenheit for 302 hours. This is one of several cases received from the same reporter. Sender's Comments: US-009507513-1709USA012766: US-009507513-1709USA007325.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included drug hypersensitivity. Previously administered products included shingles vaccine with an associated reaction of herpes zoster (previous vaccination had years before the time of reporting). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site swelling and injection site erythema. The patient was treated with Ice Pack. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site swelling and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: Approximately 6 months before the time of reporting, the patient received 2nd dose of SHINGRIX on an unknown arm. After vaccination, the patient experienced a sore arm with swelling at the injection site. The patient also experienced redness, which occurred at the very upper part of her arm. The patient put some ice on the area and the issues were resolved in a couple of days. The patient also claims that, when the patient as a young child and received a diphtheria shot and she felt like she was going to faint. The next time the physician divided the vaccine into two portions and her issue resolved. No additional details were available. The reporter did not consent to follow-up.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: radiating pain/numbness in arm
I had vaccine given to me on 11/23/10. I had severe pain, swelling, a huge lump very red and warm at injection site until 12/10/10. There is still a small bump at site of injection, 12/15/10.
Moderna COVID 19 Vaccine was given to a 17 year old.  No physical adverse reactions were noted
8/20/03 Mom noticed rash beginning on abdomen, fever 100.4 noted then and has continued. Rash spread to chest, neck, face and extremities. Mom given Tylenol every 4 hours. on 8/25 at 2AM, mom report baby crying out - irritable. Mom questioned ear infection.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients' of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On unknown dates, these patients' were vaccinated with improperly stored doses of ROTATEQ (lot # M016238, expiry date 07-DEC-2017) (strength, dosing details, anatomical location were unknown). No adverse effects were reported. The vaccine underwent temperature excursion of 1.6 degree Celsius for 2 hours and 1.7 degree Celsius for 1 hour 30 minutes. Data logger involvement was unknown. There were no previous temperature excursions. No product quality complaint was involved. This report is linked with case # 1611USA006564, due to same reporter source. Additional information has been requested.
91 year old lady with hx permanent atrial fibrillation on xarelto, COPD, long term smoker, remote pneumonia 2018, has not been hospitalized since 2018, was brought in for evaluation of lethargy and confusion and weakness and loose stools and loose congested cough. In the ED she was hypotensive 84/48 which improved to 117/66 with 1.5 liters of IVF. She is rate controlled. She is now responisive and able to provide information. She is afebrile. Cultures done in ED. Lactic acid is flat. She has been weak and having the symptoms x a week and tested positive COVID 19 last wednesday 12/29/21. She denies chest pain or sob, she has long term COPD. CHest xray essenitally unchanged from previous but has slight increased haziness in the bases with COPD changes.
STERILE WATER FOR INJECTION WAS MIXED IN AS A DILUENT.  NO REPORTS OF ANY ADVERSE REACTIONS REPORTED TO PHARMACY AT THE TIME OF THIS REPORT
Localized reddened area 50mm in circumference, warm to touch. No other symptoms. May or not see PCP. As of 10/10/13, no further communication with patient.
Menveo reconstituted with different diluent; Menveo administered with different diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 31-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31st October 2023) for prophylaxis.   On 23rd September 2022, the patient received Menveo. On 23rd September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid to a patient. The reporter asked how to proceed with patient vaccination. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, the administration of Menveo which was reconstituted with a different diluent than the supplied meningococcal CYW-135 (MenCYW-135) liquid to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Getting a some itching on my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Getting a some itching on my arm) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Getting a some itching on my arm). At the time of the report, PRURITUS (Getting a some itching on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
A rash at the injection; Swelling at the injection site; Severe itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VITAMIN D NOS, CALCIUM and MAGNESIUM for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site). The patient was treated with FLUOCINONIDE at a dose of UNK dosage form. On 31-Jan-2021, VACCINATION SITE RASH (A rash at the injection), VACCINATION SITE SWELLING (Swelling at the injection site) and VACCINATION SITE PRURITUS (Severe itching at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.