chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 04-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. The patient's concomitant medications were not reported. Past drug history included: Zantac, reaction(s): "known allergies: zantac", notes: known allergies: zantac.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Rt arm swelling and induration approx. 20x10 cm. Also had fever 100, heaviness of chest and general malaise. Continue with ibuprofen which she was already taking. ?Cellulitis put on KEFLEX.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 19-JAN-2018, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #N026288, expiry date: 08-FEB-2020). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012320: US-009507513-1802USA012323: US-009507513-1802USA012317.
Seen today, after vaccination on 3/13/01 into left deltoid for local erythema, edema, tenderness, generalized body aches, headache, low-grade fever, chills, dry hack-like cough and bilateral conjunctivitis.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, since 17-SEP-2014, unspecified number of M-M-R II doses (dose, route and lot number not provided) had been administered to patients, (exact dates not specified). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Headache, nausea, chills, body aches, sore large swollen area in arm pit, sore arm
patient's vaccine was administered at 3:40pm, he disclosed that he had passed out after a vaccine previously so I advised that he could wait 15 minutes in the post-vaccination area but not to drive for 30 minutes.  At 3:44pm the patient was waving at me indicating that he felt dizzy so I ran out there and he asked for ice and said he was feeling lightheaded and seeing black spots.  I asked him to lay on the floor with his feet elevated in a chair. He stayed that way for a few minutes and said he was feeling better, and we were able to get him a cool pack.  He sat up on the floor and put the cool pack on his neck.  After a few minutes he was feeling better so I allowed him to remain seated in the chair until 4:10pm.  Store management came to get a statement from him and he ended up staying in the pharmacy area for approximately 1 hour post-vaccination.  He waved and thanked us when he left.
Pediarix, single dose hepB / single dose Polio, all at 2 month visit / was human error; This case was reported by a other health professional via sales rep and described the occurrence of accidental overdose in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hepatitis B vaccine for prophylaxis and POLIOMYELITIS VACCINE (POLIO VACCINE) for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Hepatitis B vaccine and POLIO VACCINE. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hepatitis B vaccine, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Health care professional reported that the patient received single dose of Pediarix, Hepatitis B and Polio at 2 months visit, which led to accidental overdose. No other information was reported. The reporter consented to follow up.
terrible leg pains every night, legs are throbbing; she can't sleep, she can't nap; legs are achy; legs feel fatigued; extreme pain in her right foot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme pain in her right foot), PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 38A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme pain in her right foot). On an unknown date, the patient experienced PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued). At the time of the report, PAIN IN EXTREMITY (extreme pain in her right foot), PAIN IN EXTREMITY (terrible leg pains every night, legs are throbbing), INSOMNIA (she can't sleep, she can't nap), PAIN IN EXTREMITY (legs are achy) and MUSCLE FATIGUE (legs feel fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
Fatigue; Chills; Fever; Severe sweating; Vomiting; Diarrhea; severe Headache; joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 10:45 (Lot number: FJ1620) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Partial thyroid removal" (unspecified if ongoing); "allergy to pineapple, kiwi" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID. Past drug history included: Biaxcin, reaction(s): "Biaxcin allergy"; Z-pack, reaction(s): "Z-Pack allergy". Vaccination history included: Bnt162b2 (Dose 1, single, lot number:Fh8030, expiry date not reported, at left arm, at 10:30), administration date: 11Nov2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Fatigue", "Chills", "Fever". The following information was reported: FATIGUE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Chills"; PYREXIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Fever"; HYPERHIDROSIS (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Severe sweating"; VOMITING (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "Diarrhea"; HEADACHE (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "severe Headache"; ARTHRALGIA (non-serious) with onset 02Dec2021 16:00, outcome "recovering", described as "joint paint and unbearable pain in my hips felt like someone was pulling each leg in an opposite direction with no relief whether sitting, standing or laying down and pain reduces does not work". Therapeutic measures were not taken as a result of fatigue, chills, pyrexia, hyperhidrosis, vomiting, diarrhoea, headache, arthralgia.  Additional Information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are needed. No further information is expected.
Felt bad, headache, body aches, fever that started 5/3/2013, general flu like symptoms. Went to a golf tournament in the cold/rain on Thursday (5/2) and Friday (5/3). Felt worse Friday and over the weekend. Still not feeling well today (5/6).
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of 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 orally administered the improperly stored doses of ROTATEQ, lot # L046320 with expiry date on 29-SEP-2017 (dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the following temperature excursions: more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47.22 degrees Fahrenheit for 5 minutes and more than 46 degrees Fahrenheit but less than 77 degrees Fahrenheit with the highest temperature of 47 degrees Fahrenheit for 5 minutes. Data logger was involved. There was no previous excursion reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA007798:
Approximately 20 hours after receiving DTaP, HIB, IPV, PCV, and ROTATEQ parents noticed pt's head swelling. Pt diagnosed with fontanel swelling d/t vaccine administration. Slight fever - Tmax 100.4. Some insomnia.
OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received primary vaccine of covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with primary dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient previously received first booster dose of covid-19 vaccine ad26. cov2. s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first booster dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). The patient additionally received second booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was an off label use and inappropriate schedule of vaccine administration (All events with dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The reporter stated that, the patient (her husband) also got a 2nd JNJ Covid-19 booster dose. The reporter stated both she and her husband got the JNJ initial, first and now, second booster dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220441017.
Soreness, swelling of arm, redness, rash, decreased blood pressure, visual disturbance, dizziness
This case was reported by a pharmacist and described the occurrence of a medication error in a 1-day-old subject of unspecified gender who was vaccinated with Fluarix (GlaxoSmithKline). On 29 November 2007 the subject inadvertently received a dose of Fluarix at 0.5 ml. This was considered to be a medication error. The dose of Fluarix was intended for the newborns mother. Fluarix is not indicated for use in subjects under the age of 18 years. The newborn was hospitalized following birth and it was unclear at the time of the reporting whether the medication error would prolong the newborns stay in the hospital. Administration of other vaccines was not known. No adverse events were reported.
Pt. marked NO to question "are you sick today?" but reported nausea to pharmacy technician.  Technician called pharmacist over to gather more information.   Patient reported nausea and headache to pharmacist but denied vomiting, fevers, diarrhea, and unusual cough (pt. said she always has cough due to allergies) but pt. was not coughing at appointment.   Patient also stated she felt well enough to receive a vaccine. 10 minutes after receiving vaccine pt. was feeling light headed and lost consciousness.  911 was called and pt. was taken to hospital.   Pt. regained conciousness after approximately 3 minutes but was in and out until taken to hospital.  Facility reported pt. being on antibiotics for UTI after pt. left for hospital but this information was not disclosed by facility or pt. prior to vaccination.
Pt recvd vax 13FEB92 & 1 to 2 days following the vax pt exp lt elbow & shoulder pain; pain was described as dull, aching pain worse p/exercise;
37yo female received first COVID vaccine lt arm on 1/15/21.  She denies any immediate adverse reactions.  Day 6 (1/22) she c/o right ear pain. 1/23 continued ear pain with nasal congestion 1/24 symptoms continue with difficulty chewing about 1100am.  1700 c/o tongue -upper lip swelling and rt facial droop, forehead-eyebrow paralysis - to ER where diagnosed with Bells Palsy. ER provider dx viral like illness and bells palsy attributed to viral prodrome.  Given tapering dose prednisone, Sudafed for congestion/ear fullness and ophthalmic eye drops.  Seen by HCP 1/27 and again 1/28 with improvement of symptoms but facial droop continues.  Pt states is better. Prescribed Valtrax Additional information for Item 18:  Medical center notified of case and monitoring.
on 4/11/2021  approximately 1pm ,  just left home from lunch and went back to work. started having chest tightness, chest pain, called wife -- he felt clammy and all around not feeling well and above symptoms. Advised him to come home- stayed on phone with him til he arrived home. took his blood pressure with wrist bp machine while sitting at dining table and it was 171/85 and pulse was 85  so called EMS.
Pt. received Hep A, Hep B, Tdap, (right arm) flu, polio, and MMR. Pt. woke up at 7:00 AM and noticed a tender, large, lemon-sized (4" x 3.5") swelling in right axilla. Pt. saw his physician this morning (2/7/2011) at his office. Physician examined the mass, and stated that the mass did not involve the lymph nodes, and advised pt. to apply ice to swelling for 15" periodically throughout the day. If swelling does not subside in 2 days, pt. is advised to see his physician again for "imaging."
12/28/20 I woke up with a fever, chills, body ache.  I went and got tested for Covid19.   12/29/20, I was informed I tested positive.   3 weeks of rest, over the counter medicine- nightquil, cold ez, Mucinex.  Prescription inhaler.
pt recv vax; states rt upper arm started swelling 14jun95 in pm; cont to swell w/ redness noted at site; exp n 16jun95; to er; adm to hosp w/ infect; tx w/ atbs - keflex;
Sore Throat; Congestion; Stuffy; Aching Arm; Stomach air bubbles; Swelling of Lymph Nodes of the neck; postnasal drip; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm) and FLATULENCE (Stomach air bubbles) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), ALLOPURINOL and MULTIVITAMINS & MINERALS PLUS LUTEIN.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), NASAL CONGESTION (Congestion), NASAL CONGESTION (Stuffy), PAIN IN EXTREMITY (Aching Arm), FLATULENCE (Stomach air bubbles), LYMPHADENOPATHY (Swelling of Lymph Nodes of the neck), UPPER-AIRWAY COUGH SYNDROME (postnasal drip) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
On day two after my shot the area where they gave me they shot was itching and had a red and hot oval spot around it. Through out the day it spread and I felt swollen down my arm and into my hand. I was also sore around my upper breast or armpit side. Today on day three it is still there and spreading around my arm. It is still itching and hot.
Shingles around the left eye and forehead area, as well as scalp. Itchiness, rash and pain, pain associated with the left eye as well Rash began 4/5/2021 Pain began 4/6/2021
This case was reported by a physician via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporting physician was the patient. The physician mentioned the adverse event as an aside and did not provide further details about lot number and vaccination dates. For tolerance to next dose, refer case US2018GSK153043.
On 2/10 she noted a line on her left wrist that was raised and bubbly. On 2/14 she woke to a rash all over her face. She went to the ER on 2/15 and the physician prescribed prednisone, Atarax and an EpiPen. She also has an appointment with an allergist on 2/22.
Pt became ill and warm all over. He described a rosacea-like rash on chest, armpit, face, neck & back. Pt still had rash on 12/19/12. On 12/20/12 pt was back to normal. Pt saw his practitioner on 12/18/12 & suggest he should take diphenhydramine.
No adverse reaction.  Pt should have received  30mcg/0.3ml. Pt received 10 mcg/0.2ml
03/31/2003: Immunization given and cellulitis started 04/02/2003 5x10cm Left thigh at site of DTAP immunization.  Started on Augmentin.  04/04/2003 seen for recheck and cellulitis resolved.
Throat is constricted; Throat is swollen; Choked on his medication; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Choked on his medication) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included SERTRALINE, TRAZODONE and GABAPENTIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced CHOKING (Choked on his medication) (seriousness criterion medically significant) and NAUSEA (Nausea). On 30-Mar-2021, the patient experienced THROAT TIGHTNESS (Throat is constricted) and PHARYNGEAL SWELLING (Throat is swollen). At the time of the report, CHOKING (Choked on his medication), NAUSEA (Nausea), THROAT TIGHTNESS (Throat is constricted) and PHARYNGEAL SWELLING (Throat is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of these events were not provided.; 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.
This spontaneous report as received from a registered nurse refers to a patient of unkonwn age and gender. The patient's pertinent medical history, drug reactions/allergies were not provided. On 02-SEP-2014, the patient received a first dose of ZOSTAVAX, .65 ml subcutaneous, (Lot # and expiration date were not provided). Co-suspect therapy and concomitant medications were not provided. It was reported that patient accidentally received two doses of ZOSTAVAX. One dose on 02-SEP-2014 and the second dose was administered on 15-SEP-2014. No adverse effects reported. Additional information has been requested.