chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received a single dose of TRUMENBA via an unspecified route of administration on 28Aug2017 for immunization. The patient medical history and concomitant medications were not reported. On an unspecified day in Aug2017 the patient experienced some swelling at the injection site which has resolved on an unspecified day in Aug2017.
pt recv vax 23SEP98 & was fussy 25SEP98;26SEP98 early hr of AM pt noted to be gasping w/eyes deviated;unsuccessful full resuscitation on immed arrival @ ER;pt was in cardiorespiratory arrest;
Shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. On an unspecified date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for long-term prevention of shingles and/or zoster-related conditions. Subsequent to the pt's inoculation, she was treated by an HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), she had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was reported as not resolved. The causal relationship of herpes zoster was reported as related to zoster vaccine live (ZOSTAVAX).
Caused a spasm of neck muscles which was very painful. This is still on going. Pain is lessened by about 50%.
The pt experienced small scattered papules all over the body. 1 small papule in mouth and 3 early scabs on trunk. Treated with Benadryl.
Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore; Pain, tenderness and swelling in the arm of the injection, the right one; Developed a hardness the size of half a dollar, it is red and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     The patient's past medical history included Mastectomy (Patient had a mastectomy in the left side in the past.). Concomitant products included LEVOTHYROXINE, LISINOPRIL, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and VITAMINS NOS for an unknown indication.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore). At the time of the report, VACCINATION SITE INDURATION (Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE PAIN (Pain, tenderness and swelling in the arm of the injection, the right on/Developed a hardness the size of half a dollar, it is red and sore), VACCINATION SITE SWELLING (Pain, tenderness and swelling in the arm of the injection, the right one) and VACCINATION SITE ERYTHEMA (Developed a hardness the size of half a dollar, it is red and sore) outcome was unknown.            No treatment medication were reported.   This case was linked to MOD-2021-396109, MOD-2021-396130 (Patient Link).
bitter metallic taste; lost appetite; numb on tongue; felt more thirsty; loss of taste; there is saliva though; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty) and AGEUSIA (loss of taste) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included PARACETAMOL (TYLENOL), MULTIVITAMIN [VITAMINS NOS] and EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (DESCOVY) for an unknown indication.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though). At the time of the report, DYSGEUSIA (bitter metallic taste), DECREASED APPETITE (lost appetite), HYPOAESTHESIA ORAL (numb on tongue), THIRST (felt more thirsty), AGEUSIA (loss of taste) and SALIVARY HYPERSECRETION (there is saliva though) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported by reporter.
Severe headache Vomiting Severe body ache Shivers Fever Chills Sweating Confusion Exhaustion Nausea
Patient developed redness and swelling at the injection site which began 3 hours after administration. This occurred approximately 3 inches from the injection site. Patient also had a white induration which has since disappeared.
THE SECOND DOSE WAS ADMINISTRED BEFORE THE 21 DAYS INTERVAL, AT DAY TEN AFTER FIRST DOSE.
she thinks his provider gave the Prevnar 13 subq; she thinks his provider gave the Prevnar 13 subq; his arm is super red; he can't lift his arm above his shoulder; severe pain; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Nov2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer received via a sales representative. A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number and expiry date were not reported), subcutaneous in arm on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient's wife reported that the patient got the shot from his primary care doctor and now the patient's arm was super red and can't lift his arm above his shoulder. It was added that it was in severe pain. The wife also reported that she  thinks that his provider gave the pneumococcal 13-val conj vac (dipht crm197 protein) subcutaneously. The outcome of the events was unknown.  No follow-up attempts are needed. Information about Lot/batch number cannot be obtained.
Do not know if reaction happened sooner because he wore long sleeve shirt that day. Arm swollen from shoulder to elbow with redness. Arm is hard like a rock with a reddish rash. Painful to the touch he says. He complaining about itching and pain mainly. Took him to urgent care at the hospital where he received his four year old boosters, they said it was localized reaction and to give him ibuprofen every 8 hours and to come back in two days for reassessment. He has slept half of the day. I also administered 5ml of Benadryl to him today.
If you hours after the injection I was having significant pain in my left arm at the injection site and throughout my shoulder muscle. Then I started to feel very tired and had flu like symptoms. I took Tylenol and rested. These effects lasted for approximately 2 and 1/2 days.
Patient presenting with a segmental pulmonary embolism 2 weeks after first dose of the Moderna COVID-19 vaccination. Has history of provoked DVT from knee replacement surgery.
Red rash on left bicep and outer arm above elbow. No pain. Started a week after injection and has persisted for the past week.
pt recvd 2 doses of Engerix-B & exp joint stiffness & aching p/2nd dose;
just a shoulder pain; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (31Jan2021), this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history included back pain. The patient's concomitant medication included tramadol for back pain and unspecified Blood thinner.   It was reported that patient already took the vaccine and was taking Blood thinner and tramadol for his back pain, wanted to know if that was okay. The patient wanted to know if the vaccine was contraindicated to be administered with people taking blood thinners and tramadol. The patient stated that he had no other side effects but just a shoulder pain around the injection site. The said it was normal for him and will go away with time. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
After administering the Pfizer Bivalent vaccine and Fluzone Quadravalent shot in the patient's left arm the patient began to feel dizzy after a minute or so.  The patient was sitting in a chair.  The pharmacist on duty went and got a instant cold pack and the mother held the cold pack on the patient's neck.  The pharmacist and mother then lowered the patient onto the floor in the Pharmacy immunization room and elevated the patient's legs onto a chair with the cold pack still located on the back of her neck on the floor.  The patient rested on the floor for about 5 minutes then sat upright in a chair in the IMZ room for another few minutes and felt ok to walk out on her own.  The pharmacist asked the Mother if she wanted the EMT called and she declined.
Drug reaction/Allergy: MMR; This spontaneous report was received from a medical assistant and refers to a currently 6-year-old female patient. The patient's medical history, concurrent conditions and concomitant medication were unknown to the reporter. On an unknown date, the patient was vaccinated with measles, mumps, and rubella virus vaccine (reported as MMR) (manufacturer unknown) (captured as measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)) for prophylaxis (dosing details, route, lot number, and expiry date were not reported). On an unknown date, the patient experienced unspecified drug reaction/allergy (allergy to vaccine). The outcome of the event was unknown. The causal relationship between the event and suspect therapy was considered related.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA004447:
Was not vaccinated according to Pfizer's product insert and the CDC guidelines/if starting the Prevnar 13 after 1 year of age that the patient should only receive 2 doses, not 4 doses.; rash on his stomach, bath, and mouth; blisters and welts around the injection site that were over 3 inches in length; blisters and welts around the injection site that were over 3 inches in length; Hives on stomach and back; Fever; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Instability walking where he would get off balance and fall; Redness around the injection site; A little tired; Not eating as much; This is a spontaneous report from a contactable consumer.  A 20-month-old male patient received third dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2019 and fourth dose on 25Mar2019 at single dose for routine vaccination.  The patient medical history and concomitant medications were not reported.  The patient previously took Prevnar 13 on 19Dec2018 and experienced bronchitis. On Jan2019, when he had the third round of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) he ended up with hives on his stomach and back, had a fever, instability walking where he would get off balance and fall. The second day he had a mild fever and redness around the injection site. By the next day he just had a mild fever and was a little tired and not eating as much. On Tuesday, 25Mar2019, he had his fourth dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). He ended up with a rash on his stomach, bath, and mouth. He had a bad fever that lasted through the night. The next day he had a mild fever and blisters and welts around the injection site that were over 3 inches in length. Yesterday, 26Mar2019, it was reported that he was taken to the urgent care where he was given steroids. He again had the instability walking and was running in to things. Her concern is that after he had these reactions she looked at an insert from pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and looked at the CDC guidelines and her son was not vaccinated according to the guidelines. The insert says that if starting the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) after 1 year of age that the patient should only receive 2 doses, not 4 doses. The outcome of the events was unknown.  Information on the batch number has been requested.
This spontaneous report as received from a nurse refers to three patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck) 0.5 ml subcutaneously. Lot number and expiration dates were not reported. No co-suspect and concomitant therapies were reported. Nurse reported that three patients were administered improperly stored doses of VARIVAX (Merck) (on an unknown date). No adverse event were reported. This is one of two reports from the same source (other case # 1407USA003655). Additional information has been requested.
Starting about 8 hours after my shot of the second dose I developed a terrible, intense pressure headache. Since then, for the past three weeks I have a headache of varying intensity everyday. My headaches do not improve with Tylenol and Advil,
patient reports lump in throat, dry mouth and dizziness.  Benadryl given, lump in throat sensation resolved.
Pain in right deltoid, moving up towards collar bone bone. Pt admits to taking TYLENOL OTC (5/3/2012) without any relief.
Pt recvd vax & 5 days later exp swollen lymph glands & had sensation of feet & arms being asleep; tingling sensation began toward the end of October 1992; exp sore throat & sinus drainage;
Patient received an expired dose of vaccine ( Expiration date: December 2nd, 2017).
Patient walked into office on 10/17/2015 with parent.  Left upper arm extremely swollen, hard, red and hot to touch. Site painful and itchy.
No adverse events at this time pt was given 0.3 ml of undiluted orange cap pediatric 5-11 vaccine (30 mcg dose) -reported since it was not the rtu gray cap adult dose
Information has been received from a physician concerning an approximately 4 month old female who was vaccinated with a second dose of Rotateq. On 12-JUN-2007 the patient developed intussusception and was hospitalized. It was reported that the patient had to have a resection of the bowel. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. The patient's intussusception was considered to be immediately life-threatening and an other important medical event by the reporter. Additional information has been requested.  09/17/2007 D/C Summary received from CDC for DOS 6/12-20/2007 for DX of Volvulus.  Infant presented with 1 day hx of increasing abdominal girth and vomiting.  Pt taken to OR for an irreducible intussusception and had a short segment of volvulus with ischemic bowel.  Pt had a small bowel resection with an ileum to R colon primary anastomosis.  Cardiology consult for sinus bradycardia determined to be a normal variant. Pt resumed feeds and was D/C home.
Vaccine vial MAY have not been diluted prior to use, as a result the patient may have received a higher than approved dose. Parent/Caregiver was notified, no concerns or adverse effects noted. 2nd dose on 04/23/22 may have also been affected.
No adverse effects were reported; The patient recieved one expired dose of VAQTA; This spontaneous report was received from an office manager, regarding a 12 year old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 24-MAY-2019, the patient was vaccinated with one expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5, intramuscular, lot number R010368, expiration date 25-MAR-2019, for prophylaxis. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA011920:
Persistent daily itching, waking with itchy red welts across skin, particularly in trunk, neck, and arms.
An 1 year old patient recieved vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other healthcare professional via Agency (Reference number- 00527580) and transmitted to Sanofi on 19-Mar-2021.  This case involves an one-years-old male patient who received 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA and expiry date: 13-Aug-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 16-Dec-2020 (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 65-year-old female patient who received SHINGRIX (batch number 9NJ59, expiry date 8th February 2021) for prophylaxis. On 17th July 2018, the patient received SHINGRIX (intramuscular). In July 2018, 1 day after receiving SHINGRIX, the patient experienced erythema. On an unknown date, the outcome of the erythema was recovered/resolved. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX on right arm. The patient experienced a local site reaction (redness) about 6 to 7 inches down from where she received the vaccine. The reaction began 1 to 2 days after she received the vaccine and lasted for few days.
I got Covid 19 while traveling. Symptoms - Temp of 102.5 F. first day, chest and nasal congestion for 5 days, residual cough for two weeks.
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival). At the time of the report, PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temperature, re-frozen at ti me of arrival) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2022-496015 (Patient Link).