chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events.; on 02-JUN-2020 a patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant, referring to a 18-year-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions/allergies and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection (lot number S022913, which has been verified to be valid, expiration date reported and validated as 19-JAN-2021) (dose, route of administration, vaccination scheme frequency and anatomical injection site were not reported) administered as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The administered dose of the vaccine experienced a temperature excursion from 15 degrees Fahrenheit (F) to 46 F (36.86 F) for a time frame of 9 hours 49 minutes. There was a previous temperature excursion reported from 15 F to 46 F (19.13 F) for a time frame of 1 hour 30 minutes. There were no additional adverse events reported. There was not a product quality complaint (PQC) involved.
Sore throat; Hot to touch injeciton site; Lump at the injection site; Swollen glands, lymph nodes in jaw swollen bilateral; Body aches; Swelling at the injection site; Pain at the injection site; Redness at and around the injection site; Fever 101.8; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot to touch injeciton site), VACCINATION SITE MASS (Lump at the injection site), LYMPHADENOPATHY (Swollen glands, lymph nodes in jaw swollen bilateral) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot to touch injeciton site), VACCINATION SITE MASS (Lump at the injection site), LYMPHADENOPATHY (Swollen glands, lymph nodes in jaw swollen bilateral), MYALGIA (Body aches), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at and around the injection site) and PYREXIA (Fever 101.8). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE WARMTH (Hot to touch injeciton site), VACCINATION SITE MASS (Lump at the injection site), LYMPHADENOPATHY (Swollen glands, lymph nodes in jaw swollen bilateral), MYALGIA (Body aches), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Pain at the injection site), VACCINATION SITE ERYTHEMA (Redness at and around the injection site) and PYREXIA (Fever 101.8) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101.8 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.
I didn't experience any symptoms other than soreness at the injection site in the 48 hours I got the vaccine on Wednesday, March 10, until Friday, March 26, where I had serious period cramps on top of fatigue, headache, fever, and chills.  In the 24 hours since the first symptom was identified, the headache and the chills disappeared, leaving a little bit of fatigue and fluctuating fever.   The last I checked, I have a 100.3 degree Fahrenheit fever.  I check my temperature every hour or so.
Late the night of the vaccination I woke up with shaking from an elevated temperature. I am ashamed to say I did not take my temperature. By the next morning my temperature was down to about 1 degree above normal. I felt "wiped out" most of the following day. However, the second night I slept well and felt much better the next morning. Other than this the only other symptom was a fair amount of pain at the injection site. That has alleviated a great deal.
Pruritus as soon as injection given then later that day large reddened area looked like a hive about the size of baseball which lasted several days.
Severe fatigue, nausea, and headache beginning within a few hours of vaccination and lasting for several days.
Patient received Pfizer vaccination on 1/15/2021 and 2/5/2021. Patient hospitalized for COVID-19 9/28/2021. Patient still currently hospitalized with breakthrough COVID-19.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 21-MAY-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50 U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 2 times with the following lowest recorded temperatures: 34F (1.111 Celsius degrees) for 88 hours and 32 F (0 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable consumer (Patient) or other non HCP from a Pfizer-sponsored program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Patient Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. On unspecified date in Aug2021, patient experienced Cold, Cough with phlegm, Cough with phlegm, pressure like as sinus on her nose, lost her smell and taste. she was worried because she was around with her mom she is with her mom with lupus (further clarification unknown), so she was worried regarding this experience as well. On paraphrasing the concern: consumer stated, she was not living with her she is just pet sitting (further clarification unknown) for her, she just want to make sure that she gets tested, she means is there any (incomplete sentence). Consumer was informed about the Role of Pfizer Drug Safety Department and Pfizer medical information department. Consumer was provided with the Pfizer Medical Information department number. consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. The outcome for the events was unknown. No follow-up attempts are possible information about lot/batch number cannot be obtained.
The patient was in his usual state of good health. He acutely noted the onset of an averse bitter taste to multiple foods/drinks (coffee/orange/pepsi sodas, wheat bread, dried raisin/apricots/trailmix) 2 weeks after receiving his first vaccine injection.  He noted along with this was a dry sensation with decreased saliva in his mouth.  One day after receiving his second injection he noted the acute onset of a strange averse smell from injecting himself with insulin. He had never noticed this smell before. He noted that his whole body has this  strange smell after injecting insulin. He states that the taste and smell changes have been getting stronger with time. He also noted to starting to have "morbid thoughts" but specifically denies any suicidal ideation of plans.  His diabetes continues to be under excellent control.
pt recvd vax & was very tired & occasional achiness; 23MAR93 pt felt had flu bug; sx were h/a, diarrhea, achiness, dizziness & general malaise; low grade fever; sweats; terrible aches & pain; nausea, visual disturbances;
Information has been received from a physician and a licensed practical nurse concerning a 73 year old female who on 09-NOV-2006, at 14:00, was vaccinated IM, into the right upper arm, with a first dose Pneumovax 23 (lot #651437/0899F). Concomitant therapy included NEXIUM, TOPROL XL and BENICAR. On 09-NOV-2006, at 22:00, the patient developed pain in shoulder radiating down to fingers of injection site arm. The patient sought medical attention and was treated with VICODIN. There were no laboratory or diagnostic tests performed. At the time of the report, the patient's pain in shoulder radiating down to fingers of injection site arm persisted. The licensed practical nurse expressed concern that three patients in the same week had these reactions and said that they were no longer giving Pneumovax 23. The nurse said that she will await results of whatever investigation will be done. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the government and was released by the regulatory agency. Additional information is not expected.
Information has been received from a nurse practitioner concerning a 16 year old white female student with irritable bowel syndrome and asthma who on 8/11/04, at 16:50, was vaccinated SC in the upper arm with the first dose of varicella virus vaccine live (lot # 647093/0886N). There was no illness at the time of vaccination. The NP reported that on 8/13/04 the patient developed several small, itchy, red vesicular lesions on both arms (patient called clinic on 8/16/04 to reported event). The NP indicated that no other symptoms were noted. At the time of this report, the patient was recovering. Additional information has been requested.
NAUSEA, CHILLS, BODY ACHES, FATIGUE, ?FEVER
Received Tdap, MENACTRA at 0845. Client then went back to class (P.E.) and had a syncopal episode at 0910. Per school district protocol client was taken to Emergency Room via EMS.
During monitoring period post vaccine, pt experienced 8/10 head pain. Emergency services was called and arrived onsite for assistance.    Vital signs taken by Nurse when I arrived onsite.
Left deltoid area reddened, firm to touch, and c/o injection area itching.
No adverse event; RECOMBIVAX HB was administered to 1 patient following temperature excursion; This spontaneous report was received by customer and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with one dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# W025778, expiration date: 11-JUN-2023, (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On 11-APR-2023, administered dose of vaccine was exposed to the temperature excursion of 50.6 degrees Fahrenheit (F) for 4 hours (product storage error). No previous temperature excursion. No additional adverse events (no adverse event).  Lot number W025778 (expiration date: 11-JUN-2023) has been verified to be valid lot number for hepatitis b vaccine (recombinant) (RECOMBIVAX HB).
Incredible arm/shoulder/lymph node pain starting 10 hours post-vaccination lasting about 60 hours. About 12 hours post-vaccine, uncontrollable muscle spasms began and lasted approximately 2 hours. In this time, arm/shoulder/lymph node were extremely swollen. During the muscle spasms, I experienced my first or two "attacks".  Speaking and thinking became difficult - at times I felt as though I was trapped in my own head unable to speak or move how I wanted (motor function was possible but sluggish and requiring assistance to become ambulatory). The worst of this lasted about 4 hours, though my brain remained some level of "foggy" 48 hours post-vaccination. 1-2 hours into these neurological issues, I lost the ability to feel throughout my whole body. I could tell there was a sensation on my skin, but I could not tell if it was hot/cold/pain/pressure.  I could not feel if I was swallowing, drinking water, or breathing, though I could move enough to perform these activities.  Vision was hazy during these attacks and for a while after. The worst of all these effects lasted 3-4 hours. It then took about 5-6 hours to regain all feeling, though my brain was still foggy/hazy. Heavy swelling lasted several hours, then became moderate swelling, and after 48 hours, there was little to no swelling. About 22 hours post-vaccination, I had another one of these "attacks", not including the muscle spasms. This second attack was identical to the first in every way, except it was slightly less severe.  Recuperation time was again 5-6 hours. It is currently about 70 hours post-vaccination and most symptoms except moderate arm soreness are gone. During both attacks, BP and temperature were normal, heart rate slightly elevated (80-85 bpm).  Other non-severe effects included fatigue,  slight chills/flush.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received on 5th May 2018, for tolerance refer case: US2018101667). On 14th July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, erythema of extremities, pain in arm and swelling arm. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, erythema of extremities, pain in arm and swelling arm were recovered/resolved. It was unknown if the reporter considered the fever, erythema of extremities, pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient experienced fever, red, swollen, painful reaction on their arm and swelling in legs which lasted for 2 weeks.
MMR-II vaccine that expired 07/07/2021 was administered to the patient on 07/13/2021 at 1150 AM.  The patient did not exhibit any adverse signs or symptoms after administration.
PATIENT COMPLAINS OF NAUSEA AND VOMITING. PATIENT HAD VAGAL EPISODE AND HIT PARKED CARS IN PARKING LOT. PATIENT TRANSPORTED BY AMBULANCE TO HOSPITAL FOR FURTHER TREATMENT.
My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid; My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 84-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "My husband and I both tested positive and we were both boosted (Unspecified vaccine), 2 boosters. My husband is 84. He tested, since he is 84 his doctor recommended that he take Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: we both tested positive after eight days; Positive, notes: he tested positive on 15; Positive, notes: he is still positive on 19 days. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, low grade fever 99.7, headache, tiredness, nausea  started 10 1/2 hrs after second dose vaccine. Fever and chills lasted  for 6 hours. Ibuprofen 600mg taken for headache twice. Headache, tiredness , nausea and feeling crappy remains. 19 hours after vaccine.  If symptoms worsen or do not improve after 48 hours, I will contact my PCP. I believe I have 2 swollen lymph nodes just above my left collar bone. I had one swollen before I received 2nd vaccine.
pt recv vax & exp rheumatoid arthritis p/vax in 1991;MD reported 2 patients;they were assigned WAES 95030732 & 95030733;no further details were provided;
Pt describe pain as deep, traveling from injection site to shoulder. On right side. The patient limits rotation of arm, especially when lifting up.
This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ, lot # L042215 expiry date: 02-AUG-2017 (route and dose were not reported). The vaccine was exposed to a temperature frame of -0.5 degrees centigrade for a duration of 5 hours 38 minutes. There were no previous excursions. The call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received form the same reporter. Additional information has been requested.
About 20 minutes after receiving vaccine, patient started to feel nauseous, slight dizzy and felt a headache coming on. Patient had to go to the bathroom and vomited twice. A staff nurse assisted her and walked her to her office where patient laid down and was covered by a blanket. An initial BP reading was 139/82. Patient laid in her office for about 20 minutes under observation but had to get up to vomit again. Patient sister in-law came to pick up patient to take her to her residence. BP taken just before leaving an hour after BP was 136/80.
04/06/2021 noticed 5 itchy red lesions on left lower leg; treated with OTC Hydrocortisone Cream 1% & ultraviolet light.  Continued to spread to right leg & back of both legs. 06/04/2021 lesion left forearm, raised, hard & painful. 06/23/2021 seen by CNP, diagnosed as psoriasis Rx Hydrocortisone 2.5% Cream 2x daily to all lesions. 07/23/2021 Psoriasis cont. to spread to arms & trunk. Dr. ordered Prednisone Dose Pack for 12 days with no relief. 08/18/2021 seen by Dr. since Psoriasis was inflammed & spreading more. Dr. ordered Cyclosporin 25 mg 2x day for one month. 09/09/2021 Rash & inflammation continued to spread to scalp. Referred to Dermatologist, MD.  09/10/21 - 09/24/21  (cont) Triderm 0.1% cream ordered for generalized psoriasis. It took away the inflammation, but continued to itch & flake.  09/28/2021 Fluocinonide 0.05% topical solution ordered to apply to scalp plaques.
parents of patients misinformed pharmacy of age of child. Child is 11 years of age. pharmacy team found out due to confirmation from insurance of patient. no issues are aware of signs and symptoms from the patient as we are unable to reach patients of child
Hard to touch around the injection site; Redness around the injection site; Soreness, tenderness and hard to touch around the injection site and hurt to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Acid reflux (oesophageal). Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Acid reflux (oesophageal), ATENOLOL and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch). At the time of the report, VACCINATION SITE INDURATION (Hard to touch around the injection site), VACCINATION SITE ERYTHEMA (Redness around the injection site) and VACCINATION SITE PAIN (Soreness, tenderness and hard to touch around the injection site and hurt to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient did not received any treatment but going to take a diphenhydramine.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Patient received first dose of Pfizer BioNTech Covid-19 vaccine. Patient reported to nurse that he felt faint and sweating. Patient reported to nurse that he had a history of anxiety. Vitals taken every 5 minutes. Patient monitored and was discharged from clinic.
Pt recvd vax & devel a red area on abdo for 30 mins then went away; then on 18MAY93 pt devel nausea & vomiting which resolved that day;
face started feeling weird/numb; face started feeling weird/numb; Swallowing felt strange; started to feel dizzy; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er 8734) via an unspecified route of administration in the left arm on 03Apr2021 at 19:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome (POTS), and Hypermobile type Ehlers-Danlos syndrome (hEDS). The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received vicodin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. 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 03Apr2021 at 19:30, the patient waited 15 minutes felt fine, when driving home face started feeling weird and numb and swallowing felt strange. She pulled over because she started to feel dizzy. Her husband came and picked up, went to hospital in case of further reaction. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events face started feeling weird and numb, swallowing felt strange and started to feel dizzy was recovered on unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient was given undiluted Pfizer Pediatric dose, resulting in higher concentration amount administered.  Per dad, patient experienced fever.
Presented to doctor's office with a rash to right arm by elbow (red and hard) on Monday, April 10, 2006. Examined by doctor.