chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B022H2A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination), POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E) and NO ADVERSE EVENT (no adverse event) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office experienced several temperature excursions with vaccine vials that were used to administer vaccination) and POOR-QUALITY PRODUCT ADMINISTERED (Temperature excursion vials that were used to administer vaccination advised that over 30-40 vaccinations were performed with vials involved in T.E). No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided.
Swelling in the arm pit of her left arm /swelling feels like a sore water pouch; Swelling in the arm pit of my left arm with small circular bruising; I have swelling in the arm pit of my left arm with small circular bruising. It hurts and aches/swelling felt like a sore water pouch; The ache was also felt through my whole arm; This is a spontaneous report from a contactable consumer (patient) via a sponsored program. This non-pregnant 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 30Apr2021 at 13:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications were not reported. The patient had not received any other vaccines in the four weeks prior to the COVID vaccine. On 30Apr2021 at 16:30 the patient experienced swelling in the arm pit of her left arm with small circular bruising. She reported it hurt and ached and she had to take ibuprofen to sleep. The ache also was felt through her whole arm. The swelling felt like a sore water pouch. The events were reported as non-serious and did not require hospitalization. The clinical outcomes of swelling in the armpit of her left arm with small circular bruising, it hurt and ached, swelling felt like a sore water pouch, and ache was felt through her whole arm were reported as recovered in 2021. It was also reported that since vaccination the patient had not been tested for COVID-19.    No follow-up attempts are needed; information about lot number cannot be obtained.
Prevnar13 and Tdap (Pentacel) vaccines mixed together in the same syringe; Swelling in the leg; This is a spontaneous report from two contactable healthcare professionals. A 2-month-old male patient (age at vaccination: 9 weeks) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13 Suspension for injection, Lot number: AL8457; Expiration date: Jul2021) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL, Lot number: UJ060AA; Expiration date: 04Oct2020); both on 24Feb2020 at a single dose, with route of administration unspecified, for vaccination. The patient had no relevant medical history and concomitant medications. On 24Feb2020, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid were mixed together in the same syringe administered to the patient. In Feb2020, the patient had swelling in the leg after (s/p) the administration of the vaccines. The patient was prescribed with cool compresses and paracetamol (TYLENOL) every 6 hours, as needed as treatment for the swelling of the leg. The outcome of the events, 'vaccines mixed together in the same syringe' and 'swelling in the leg', was unknown.  Information on the lot/Batch number has been requested.  Follow-up (25Feb2020): New information received from a contactable healthcare professional included: new reporter, updated suspect vaccine (TDAP confirmed as 'Pentacel'), suspect vaccine details, and new event (swelling of the leg).
Developed 3 to 4 itchy hives on my legs and thigh 1 to 4 days after receiving my first vaccine.
Client states he was nervous, felt dizzy, fell to the floor, hit the back if his head. Client states he never lost consciousness and that he had eaten before coming to the clinic. No lump noted or felt to the injury site. Client was placed in trendelenburg position. BP lying 90/55 & 111/68 pulse 87, BP sitting 117/79 pulse 87 132/47 pulse 79 132/73 pulse 78 112/99 pulse 71. BP standing 119/74 pulse 85
HEADACHE; CHILLS; feeling QUEEZY; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced headache, chills and queasy. On an unknown date, the outcome of the headache, chills and queasy were unknown.   It was unknown if the reporter considered the headache, chills and queasy to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix and had chills, headache and was felt queasy. The reporter would like to know if she could take Tylenol. The reporter disconnected the call when asked to provide her name and contact information.  The reporter was unable to obtain any patient information or HCP (health care professional) information.
The next day after the vaccine I developed a severe migrane, nausea and vomiting for about 3 days.  Then the Tues or Wed of the next week another UTI developed but resolved on its on.
Swelling in axilla on same side as vaccine. Vaccine given in deltoid. Swelling in axilla. Does not appear to be infectious; no redness, no temperature. No parasthesia to hand. Parasthesia to site only. Started the day after the vaccination, which was
felt hot at night, fatigue for 24+ hours.; felt hot at night, fatigue for 24+ hours.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EL3302) at the age of 83 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: still experiencing), administration date: 16Jan2021, for COVID-19 IMMUNISATION, reaction(s): "stroke-like symptom"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for COVID-19 Immnunisation, reaction(s): "left arm droop"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for COVID-19 Immunisation, reaction(s): "no feeling on left side"; Bnt162b2 (Event start date: 19Jan2021, Admission to hospital due to event: Yes, Treatment received: Yes, Still experiencing: Fine now), administration date: 16Jan2021, for Covid-19 Immunisation, reaction(s): "Loss of mobility in left arm", "Droop on left side of face". The following information was reported: FEELING HOT (non-serious), FATIGUE (non-serious) all with onset 06Feb2021, outcome "recovered" (07Feb2021) and all described as "felt hot at night, fatigue for 24+ hours.".  No follow-up attempts are possible. No further information is expected.
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. Healthcare worker reported that unspecified doses of improperly stored PEDVAXHIB (lot#, dose/dose number, route, duration were unspecified) were administered to the unspecified patients on unspecified dates. No concomitant therapy was provided. No adverse effects reported. This was one of several reports that received from the same reporter. Additional information has been requested.
Patient came in to store 4/16 -- he mentioned the day of vaccine that we was uneasy on his feet that evening. ( did not mentione until 4/16.)   HE said around 4/11- 4/12 he has cold sweats, dizziness and some coughing started.   He said he started to feel better but noticed 4/16 that he was having a little shortness of breath/congestion -- he is taking mucinex to relieve congestion
Midnight pt went to bed fever 101, achy, chills, lump under injection site. Pt states slept through it felt much better, normal the next morning.
Child cried afer immunizations were administered in thighs bilaterally.  Grandmother gave child tylenol before shots were given. Instructed grandmother to put cool washclothes  on childs legs to help with the soreness.  She called back today and said that the child got a very high fever and stated having seizures Saturday night. Stated that baby would not sleep unless someone was walking around with him.  His skin was bright red from the waist down.  Grandmother stated that he had approx. 10-15 seizures.
Two days following the FLUZONE HIGH-DOSE 0.5ML I had serious intestinal cramping (never had anything like this in the past), had to leave my game of golf and drive home where I had explosive diarrhea with cramping throughout the day. The pain and diarrhea continued into the next day.
For 3 days following the day I received the vaccine, my injection site was red, itchy, hard and a swollen lump the size of a quarter,maybe even nickel sized.  After day 3, the lump had subsided and so had the itching, pain and redness.   Now today, day 7 after receiving the vaccine, my injection site is itching so badly it almost burns, it is swollen and back to a red lump nearly the size of a half dollar. I have also developed a dry cough and have overall not felt well since 1/4/2021.  Please advise
Patient was given a pfizer covid-19 vaccine from a non-reconstituted vial. When my tech prepared the vaccine and presented the syringe to me for the final verification it was correct at 0.3mL, however I was unaware that the vial had not been reconstituted
Patient received vaccination and was told to sit in waiting area for observation. Patient chose to sit in car in parking lot. Family member ran inside to alert pharmacy staff that patient had passed out and might be having seizure. Patient was unconscious for approximately a minute. Patient was awake when staff went outside. Patient requested an ambulance be called. Family believed it might have been because she hadn't eaten since breakfast. Paramedics arrived and took patient to hospital.
Received her 2nd (In the set of three) IM injection in her left upper arm while standing in the doctor's office.  She was unaffected initialy and left the office walking and talking and in no apparent distress.  Immediately upon exiting the docor's office however she lost consciousness and collapsed in the hallway, striking her head on the tile floor.  She regained consciousness immediately but complained of dizziness and head pain.  She was removed back to the doctor's office where her vital and neuro signs were assessed. Her vital signs were BP 110/70, pulse 72, resp 20; there were no postural changes to her blood pressure.Her neuro exam was also unremarkable; PERLA, hand grasps equal and she was completely orientated to person, time and place.  As she is diagnosed with a rare bleeding disorder, Factor 7 deficiency, a call was placed to her hemotologist to determine further treatment.  This physician felt that a CT scan of her head was in order due to her continued complaints of head pain and dizziness.  She was then taken to another hospital where the CT scan was performed. She was then directed back to the pediatrician's office where we waited for her test results.  The radiologist called to report a negative finding and was discharged home with 48 hour head trauma precautions.  24 hours later her headache was much improved and the dizziness has disappeared.
Pain in extremity; very itchy; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH PRURITIC (very itchy) and PAIN IN EXTREMITY (Pain in extremity) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (very itchy) and PAIN IN EXTREMITY (Pain in extremity). At the time of the report, RASH PRURITIC (very itchy) had resolved and PAIN IN EXTREMITY (Pain in extremity) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The dates of the vaccines are unknown, but they were over 6 months ago. The patient is in 50s. Patient want to know whether should get the booster.  Concomitant medications were not provided.  Treatment information was not provided.
Ambulated to Employee health c/o itching all over her skin, felt like she couldn't stand, hands and legs were numb. Flush face. Transported to the ER.
Approximately 2 days after the vaccine, patient reports having a fever, rash, burning, and swelling on arm. Four days post-vaccination symptoms seem to be improving.
hypertension; headache; a tiny nose bleed; low grade fever; stiff neck; This is a spontaneous report based on information received by Pfizer (manufacturer control number: EC-2021-091102). contactable consumer female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as single dose for covid-19 immunization; lenvatinib mesilate (LENVIMA,Lot number was not reported), oral from 06Apr2021, at 20 mg, daily for endometrial cancer. The patient's medical history and concomitant medications were not reported.  On 07 April2021 she experienced high blood pressure of 162/78, headache, a tiny nose bleed, low grade fever and stiff/sore neck that lasted 1.5 days but she is feeling better today and blood pressure was back down to 109/65 without any treatment. Patient contributes above symptoms to the Covid vaccine and not to Lenvima. The outcome of the events were recovered on 09Apr2021.
Pt received PNEUMOVAX 23 8/31/15; fridge temps were off during that time and we were instructed to re-vaccinated. Pt came back on 11/16/15 and received PNEUMOVAX 23 in (L) deltoid and flu vaccine (R) deltoid. Later that evening arm became swollen, red and painful. Seen by provider following day on 11/17/15. Treated w/ KEFLEX and BACTRIM.
pt recvd Hep B vax on 14FEB92 & the following day pt had a red blotchy spot on sterum & lt shoulder; also exp swolleing of throat, urticaria, mild SOB, hand & body swelling & tightness in chest; pt felt was having an allergic react;
Patient received 2 doses of RSV vaccine (Arexvy) on 08/19/2023 and 10/16/2023.  Patient has not experience any side effects/adverse events.
Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache; This is a spontaneous report from a Non-contactable Physician (patient). A 35-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) , via an unspecified route of administration on 23Dec2020 at first single dose at arm left for covid-19 immunisation.  The patient received the vaccine at hospital. Medical history included migraine, dermatitis atopic.  The patient's concomitant medications were not reported.  The patient experienced Rash, bilateral paresthesias in hands and feet in stocking glove distribution, fever (Tmax 101), arthralgias, myalgias, nausea, headache on 24Dec2020. No treatment for events. The outcome of events was recovered. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Approximately 29 weeks pregnant (due July 9, 2021) when I developed a persistent, non-productive cough at the end of April 2021. Received pertussis vaccine May 3, 2021, which resulted in 2 days of aches and malaise, and then increased coughing that has continued until today June 8, 2021. Went to urgent care clinic May 14, 2021 and diagnosis there was allergies.
5min after receiving VARIVAX, pt c/o ST, nausea, sneezing.  No rash.  BP 98/70.  No SOB.  R eye puffy.  1 1/2 tsp oral BENADRYL given with no imp. pt.  Transported to ER via paramedics.
This spontaneous report was received from a licensed practitioner nurse referring to a 15 month-old child of unknown gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 16-JUL-2015, the patient was administered an improperly stored dose of LIQUID PEDVAXHIB injection (lot # K026533, with expiration date: 07-AUG-2017; dose, frequency and route were not reported). No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
19Jun90 pt vax; later became irritable & could not sleep.  Vomited once.  20Jun90 appetite decreased, & had awful, total personality change.  Pt was afebrile & had no other vomiting.  Tx w/ APAP w/ codeine.
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 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Dec2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pericarditis" (unspecified if ongoing). There were no concomitant medications. Other medication in 2weeks was reported as No. No Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Indication: Covid-19 treatment; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with anti viral COVID 19 treatment Paxlovid started on 28Jun2022 and stopped on 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Info has been received from an office manager concerning a male pt who was vaccinated in his left arm with a dose of pneumococcal vaccine 23 polyvalent. Concomitant vaccination included a dose of influenza virus vaccine in the right arm. Post vaccination the pt developed swelling and difficulty lifting his left arm. The reporter indicated that a pt was treated with antibiotics, but did not specify if it was this pt or a second pt (WAES #0210USA02466) that experienced an adverse event post pneumococcal vaccine 23 polyvalent vaccination. Unspecified medical attention was sought. Additional info has been requested.
I developed a few red spots on the right side of my chest and shoulder on Thursday, May 6th.  The red spots grew, began to develop blisters and multiplied over the next few days. On Tuesday, May 11th I saw APRN, NP-C at the clinic. She diagnosed me as having shingles. She prescribed Valacyclovir HCL 1Gm for 7 days and Gabapentin 300mg tablets to use as needed. At the time, she did not feel that it was related to the vaccine. On May 13th, I returned to the clinic as the Shingles had got progressively worse and was seen by doctor, who is doing a residence under M.D. Both doctor's felt that the vaccine could have contributed to the diagnosis. They prescribed Prednisone 30mg for 3 days, 20mg for 3 days, and 10mg for 3 days, as well as 3 more days of Valacyclovir HCL 1Gm. At this time the blisters are getting smaller and the rash is subsiding and beginning to scab over in places.
Fever of 100.2. Redness on arm from shoulder to elbow. Sick to stomach.
6/9/06 Vaccines. 6/13/06 Fever 101. 6/14 MD treated with Ibuprofen and Tylenol. 6/19/06 To ER, BP 50/34. Admitted. Fever as high as 102. Multiple MD's. Infectious control MD. Not sure of diagnosis or progression of illness. Treated with fluids, antibiotics. Fever down to 99 degrees 6/19/06.