chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hives on her back, chest, neck and head; Shaking; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her back, chest, neck and head), TREMOR (Shaking) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced URTICARIA (Hives on her back, chest, neck and head), TREMOR (Shaking) and CHILLS (Chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 19-Nov-2021 for Hives, at a dose of 2 Benadryl and PARACETAMOL (TYLENOL [PARACETAMOL]) on 19-Nov-2021 at a dose of UNK dosage form. At the time of the report, URTICARIA (Hives on her back, chest, neck and head), TREMOR (Shaking) and CHILLS (Chills) outcome was unknown.            Patient received the first dose of Pfizer( EL6204) and second dose of Pfizer (EP6955) on unspecified dates and didn't experienced any side effects for both the doses.  No Treatment medication was reported.
expired was administered with no reported adverse event; Initial information received on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who was inadvertently given expired product influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Oct-2022,the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UT7378MA, expiry date: 30-JUN-2022) 0.5ml (milliliter) total at once (strength: unknown) via intramuscular route in the left vastus lateralis for Immunization.  On 07-Oct-2022 the patient was inadvertently given expired product with no reported adverse event (expired product administered) same day following the administration of vaccine.  No lab data reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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
Pain in arm; Underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4H9G2, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 2nd dose of Shingrix .5 ml. On 15th July 2019, immediately after receiving Shingrix, the patient experienced pain in arm and underdose. On an unknown date, the outcome of the pain in arm and underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: This pharmacist reported that the patient had pulled away from while being injected due to pain in their arm.  It was not pain from the needle being injected but was felt when the solution was being administered. The reporter consented to follow up. This case is 1 of the 3 linked cases, reported by the same reporter.
Had SHINGRIX shot and had soreness at injection site but have severe nerve pain in the upper and lower teeth on left side.
Patient reported having a red rash from her shoulder to her elbow and axilla region after receiving her pneumonia shot.
Patient fainted after recieving vaccine on 8/29/2021. Reaction started about 5 seconds after withdrawl of needle from arm. Patients mother was in the room and made us aware of situation prior to giving vaccination. Patient was able to respond briefly to questions, regained color in face after lying on floor for 5 minutes. Patient remained breathing the entire time, fan pointed at patient, wet wash cloth on neck helped as well , no vomiting occured.
Pt recvd vax 10NOV92 & 24 hrs p/immun twin awoke from nap, w/red, urticarial, pruritic area @ inject site & swelling down to elbow; resolved completely by 13NOV92; not seen by MD;
The next morning after my vaccination, I had extreme lower  and mid back  pain that was stabbing. It was so severe that I was crying. Then neck pain in the back  and sides of the neck so severe that I could not turn my head.  I also had severe bone pain in my legs and toes and fingers. Later in the day, I had severe nerve  pain all over my body. Also had eye pain. This lasted  two days. Four days later, I still have a headache, but Tylenol got rid of it.  I?ve had six vaccinations and this is the only one that I experienced  a severe reaction.. This reminded  me of symptoms that I had when  I was 26 and had chicken pox.
On July 11th in the afternoon she felt very dizzy, very feverish 'like 200 degrees', and naseated with vomiting.  Called her doctor who called an ambulance for her and was taken to the hospital.  She was diagnosed with acute benign vertigo of peripheral origin on right side where she had received the COVID vaccine, and bacterial pneumonia.  She had received a pneumonia vaccine in the past.  EKG and CAT scan were normal.  She reports taking  2 antibiotics currently for the pneumonia.  She had recovered from a COVID infection in November.
mom called & reported that pt devel whelp-like red rash on torso, under rt arm & 6 areas on face;pt c/o itching;afeb but whelp area warm to touch;mom notified peds who is treating w/DPH;rash devel 21hr p/vax;
Came down with COVID; Came down with COVID; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient's father) reported that a female patient (reporter's daughter) of unspecified age received bnt162b2 (COMIRNATY) first dose and second dose, both on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. His daughter was fully vaccinated. Attended a swim team meet and greet when she arrived at college. Approximately 40 in attendance and all 40 came down with COVID. Her symptoms were very mild (congestion, loss of taste and smell). She was quarantined but then returned to school activities and sports. Event took place after use of product. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Began with abdominal cramping on evening of 8-5-10 continuing into hemorrhagic diarrhea on 8-7-10. Treated with probiotics, steroid taper and homeopathic therapy.
Patient age was calculated incorrectly to be 12 years old and the Pfizer formulation for 12+ (30 mcg) was used instead of the age-appropriate 5-11 10 mcg/dose formulation.  Patient 11 years 10 months at current time.  Patient tolerated the vaccine well with no ADR's.
9/29/11 Received FLUVIRIN at appx 8am. Presented to the HC at 6:30pm with hives on entire body. BENADRYL given. Lips & tongue appeared swollen. EPIPEN administered. Transported to hosp ER. SOLU-MEDROL given in ER. Discharged on Prednisone.
Patient arrived to Covid 19 clinic to recieve a Covid 19 vaccine # 2.  The vaccine was to be given IM in the deltoid muscle but was given too low to be given in the deltoid muscle. It is believed that the Covid 19 vaccine was given in subcutaneous tissue.
rash all over their body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over their body) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (rash all over their body). At the time of the report, RASH (rash all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Took #1 oral typhoid on 02/12/2002 and sx began. Fever and chills at NOC no appetite, bad diarrhea, sneezing (no cough or sore throat) sweating at NOC and chills. Now 02/25 slept well last night but still exhausted.
horrible, debilitating stomach pain, the pain was actually from the top of throat down to lower stomach and felt like somebody ripped out the guts; the pain was actually from the top of throat; mostly a feeling having been punched in the gut and insides were put through a ringer; extreme nausea; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 23Mar2021 13:45 (lot number ER2613) at the age of 56-years (as reported) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epstein barr virus" (unspecified if ongoing); "allergies: comparing, many antibiotics" (unspecified if ongoing); "thyroid" (unspecified if ongoing). Concomitant medications included: CLARITINE and, vitamins. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "horrible, debilitating stomach pain, the pain was actually from the top of throat down to lower stomach and felt like somebody ripped out the guts"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "the pain was actually from the top of throat"; GASTROINTESTINAL PAIN (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "mostly a feeling having been punched in the gut and insides were put through a ringer"; NAUSEA (non-serious) with onset 2021, outcome "recovered with sequelae" (2021), described as "extreme nausea". Therapeutic measures were not taken as a result of abdominal pain upper, oropharyngeal pain, gastrointestinal pain, and nausea.  Additional Information: There was no cramping, no diarrhea, no vomiting. The patient doesn't know how else to explain this as she hasn't experienced this type of pain before. The patient didn't have covid-19 prior vaccination. The patient was not tested for covid-19 post-vaccination. No other vaccines were received prior to the covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.  Follow-up (12May2021): Follow-up attempts are completed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 14-JUN-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX, is intended to prevent.  On or about 05-JUL- 2016, the patient was treated by a physician and diagnosed with severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Was really itching in my head; started itching all over my trunk, the trunk of my body and I had huge rash all over my stomach; Was really itching in my head; started itching all over my trunk, the trunk of my body and I had huge rash all over my stomach; This is a spontaneous report from a contactable Consumer (patient). A patient of an unknown age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) Via an unknown route of administration on an unknown date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: not reported) as dose 1, single via an unknown route of administration on an unknown date for Covid-19 immunisation. On 03Mar2021, It started on he's back.  Patient experienced itching, itching in he's head and all of a sudden yesterday and day before yesterday he started itching all over trunk, the trunk of body and  had huge rash all over he's stomach. He feel like it is an immune response. it is really itchy and large. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Six days after the 1st vaccine, but 10 days after travelling, I developed a cough, cold, extreme tiredness and sore throat.  No fever,
Arm (upper-left) became swollen & red 12/8/10 early AM - Given IBU x 1 dose & went to school - swelling went down to mid-forearm after nap - came to Health Dept examined by center mgr & RN - advised ice - IBU - observe - ER of worsens.
Pt received first shot of Pfizer vaccine on 5/14 - 12:30 PM EST. On 05/17 around 7:45 AM, Pt passed out/fainted. He woke up few minutes prior to the event and this event started after he passed urine. As soon as he finished Urination, he felt nauseated, dizzy and then lost consciousness thereafter. He fell backwards as a result and hurt his back as well as back side of the head. During his unconsciousness  his body was completely stiff and his eyes were rolled back. For few seconds then he became completely still (it felt he was not breathing). I gave him physical stimulus (slight slaps on the face) post which he started reviving. During this time we called 911. I gave him few sips of water forcibly and he started reviving thereafter. on 5/15 and 5/16 (post vaccination on 5/14) he was feeling tired and seemed bit dull. This was unusual as Pt is a competitive soccer player and highly active.
I do not have period for that entire time but on 6th months to the day my periods came back; 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 female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Feb2021 17:15 (Lot number: EN6202, Expiration Date: 30Jun2021) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (first one EL9269, 1st dose on 04Feb2021 05:15 PM on Right Arm, Batch/Lot number: EL9269, Route of administration: Intramuscular, Amenorrhea onset date-24Feb2021, required visit to Physician Office got recovered on 14Aug2021.), administration date: 04Feb2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "Amenorrhea".  The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "recovered", described as "I do not have period for that entire time but on 6th months to the day my periods came back". The event "i do not have period for that entire time but on 6th months to the day my periods came back" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient reported that she had a side effect that she wanted to or adverse reaction that she wanted to report. Patient periods came back, 11Aug and she thought maybe it was a fluke but now my periods are regular just like they normally have them. So, she thought it might have been the vaccine. she had her period in Feb before her vaccine then she haven't had one in Mar. Patient went to the doctor they told that she was crazy the things that they did not think of and she had some X-ray and lab work done, had a physical, annual checkup. Everything was fine beside the things little bit.  No follow-up attempts are possible. No further information is expected.
2 hours after injections in left leg Hib/PREVNAR family reported leg swelling and redness past knee. TYLENOL given swelling resolved. Fussy and hard to console. On recheck exam some swelling at injection site. Outline of band-aid adhesive could be seen.
BODY PAIN; UNABLE TO SLEEP FOR 3 DAYS; ITCH OVER 100% OF BODY; BEAU'S LINES; FEVER OF 103.3; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced body pain, unable to sleep for 3 days, itch over 100% of body, beau's lines, and fever of 103.3. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.3 (unit unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 103.3, body pain, unable to sleep for 3 days, itch over 100% of body and beau's lines was not reported. This report was non-serious.
left arm hurt (1st dose); aches (1st dose) for a few days/pains (1st dose) for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Cataract. Previously administered products included for Drug use for unknown indication: FLU. Past adverse reactions to the above products included No adverse event with FLU. Concurrent medical conditions included Seasonal allergy, Muscle ache and Depression. Concomitant products included FISH OIL and ZINC for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days). At the time of the report, PAIN (left arm hurt (1st dose)) and PAIN (aches (1st dose) for a few days/pains (1st dose) for a few days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.  concomitant drugs includes eye drops were used to treat cataract ,vitamins,fluid pill   This case was linked to MOD-2021-420631, MOD-2021-420632.
pt w/t105, irregular breathing & vomiting started fever of 104-105 day following DTP; mom took pt to MD who stated pt allergic to shots; pt given APAP & recovered;
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 12-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt recvd vax 2FEB92 & swelling appeared in deltoid area on 3FEB95; c/o feeling hot;
Blood was running down after injection; Stiff arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood thinner. No treatment information was provided
10:09: Shingrix Administered to RD, patient instructed about ADE's and to stay within pharmacy range for 15 - 20 minutes 10:14: Saw that patient was rocking/swaying in his chair in the waiting area. Wife states to call EMS, my technician does so as I go out with an epinephrine pen and assess the patient. His eyes closed, unresponsive, consciousness fading, breathing was shallow, faint into no breathing.  Wife states that the pulse was low after assessment (she is a nurse). Epinephrine indicated, administered 0.3mg pen into the upper left thigh for 10 seconds. Patient regained consciousness and responsiveness.  10:25 am: EMS arrived  and began their assessment, loaded patient onto a gurney as he experienced a second bout of syncope and headed to Hospital.
Soreness at injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness at injection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concomitant products included CEFALEXIN (CEPHALEXIN AMEL) for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at injection). On 07-Mar-2021, VACCINATION SITE PAIN (Soreness at injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided. Reporter wants to know about the reaction between vaccine and antibiotic.
A week after injection Right deltoid became swollen with 2 knots in right arm. It has heat and  itches. The next day woke up and it was still swollen, red,  and itched but only had one knot in the right arm. Thought it was getting better. Then the following day 2 knots appeared.
Nurse administered Pfizer on a patient who received a Moderna Vaccination #1 on 11/29/2021, there were no symptoms