chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US012074, is an initial spontaneous report received from a physician on 13 Jun 2014, and with a follow up report received from physician on 28 Jul 2014 and a follow up received from physician on 25 Aug 2014. This report refers to a 19-year-old male patient. Relevant medical history was none and concomitant medications were not reported. Vaccination history included three doses of VIVOTIF on 30 May 2014, 01 Jun 2014 and 03 Jun 2014 respectively. He was vaccinated with first dose of pre-exposure series of RABAVERT (batch number: number: 534011A, expiration date: 30 Sep 2016) intramuscularly into the left arm deltoid on 05 Jun 2014 at 02:52 PM along with VIVOTIF fourth dose orally and IXIARO. On 06 Jun 2014, about 24 hours after vaccination, he experienced vertigo which continued to worsen and ataxia. He visited the urgent care and was treated with meclizine. He could not get off his couch for three days and had nausea but did not vomit. On 11 Jun 2014, he was able to get out of his house and vertigo started to dissipate. He visited a physician and had few residual symptoms. His balance was fine and he could turn his head. The patient completely recovered on 13 Jun 2014. The seriousness and causality of the events were not reported. He was due for his second dose of pre-exposure series of RABAVERT which was not administered yet at the time of this report (incomplete course of vaccination). Follow up report received from physician on 28 Jul 2014. Updated patient details, concomitant vaccination and outcome of events. Follow up received from physician on 25 Aug 2014: Updated patient demographics, RABAVERT batch number expiration date, time of vaccination, new event (ataxia) and other clinically relevant information.
Hemoglobinuria brownish; pain at injection site left arm; body ache; chills; Fever; headache; Nausea; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBINURIA (Hemoglobinuria brownish) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site left arm), PAIN (body ache), CHILLS (chills), PYREXIA (Fever), HEADACHE (headache), NAUSEA (Nausea) and FATIGUE (Fatigue). On 31-Mar-2021, the patient experienced HAEMOGLOBINURIA (Hemoglobinuria brownish) (seriousness criterion medically significant). On 31-Mar-2021, PAIN (body ache) and CHILLS (chills) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HAEMOGLOBINURIA (Hemoglobinuria brownish), VACCINATION SITE PAIN (pain at injection site left arm), PYREXIA (Fever), HEADACHE (headache) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications reported. Treatment medications included paracetamol 5 doses on 30 Mar 2021 and 1 dose on 31 Mar 2021.  This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to (E2B Linked Report).; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of Hemoglobinuria and expected vaccination site pain, pain, pyrexia, chills, headache, fatigue, nausea. Event onset Day 2 after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
At 11pm, while resting, felt racing heart, 97-107 beats per minute. Flushed and skin was hot but temperature was 98.6. Upon standing heart rate was 138 and was nauseous without vomiting. Symptoms subsided after 3 hours.
pt recvd vax 25FEB93 & approx 1 month later pt devel elevated SGOT levels; No further details were provided;
received Pfizer vaccines on 12/21/20, 1/12/21 Tested positive for COVID-19 on 3/22/21 Onset date of symptoms 3/22/21 w/ chills, cough, myalgia, sore throat, H/A
Rash appears in patchs on bicep and deltoid. Low grade fever. Patient states arm is extremely tender to the touch, extremely warm to the touch. Clincian states possible infection due to vaccine given too low. Patient recieved antibiotic course.
Itching in upper arm 8 hours after injection. Upper arm "dull ache/pressure" 24 hours after injection. Dull ache and pressure down into forearm 36 hours after vaccine.
Tested positive for Covid 3 months after vaccine. Had severe flu-like symptoms for about 4 days then gradually got better.
Patient called 5 hours after receiving the shot to say that he has developed 2 contiguous lines of welts on either side of his spine all the way from his neck to his tail bone. He said he was experiencing pain, itching, redness and swelling in the affected areas. He noticed the welts seem to subside with oral BENADRYL but would return.
Onset of symptoms was about 15 hrs following injection: Severe reflux and gastric distress (nausea); chills; fever to 100.8; muscle, bone and joint aches; severe fatigue; weakness; slight headache, no appetite. Alleviated somewhat with naproxyn sodium and benadryl. I also felt like I had cardiac arrhythmias. Slept most of day on 2/27. Felt improved morning of 2/28 and back to "normal" Monday 3/1.
Red itchy rash on my right arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient reported for herself). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202), second dose via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing Verbatim: Hypertension. No investigation assessment was reported. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. Historical vaccine given to patient previously was bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269), first dose via an unspecified route of administration, on an unspecified date (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. On 07Mar2021, the patient experienced red itchy rash on my right arm. Consumer stated that, "I had my second Pfizer Vaccine on Thursday and yesterday Sunday I woke up with a large rash, up and down my arm. I had the vaccine on my left arm, and I woke up on Sunday with a rash on my right arm, a red itchy rash on my right arm three days later. Is that normal? It was Pfizer COVID-19 Vaccine." Therapeutic measures were taken as a result of red itchy rash on my right arm with Benadryl. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
1) Raised, red, warm to the touch, inflammation at injection site (about 3 inches in diameter) 12 hours after injection. 2) Severe joint pain with about 6 hours after injection.  Treatment: Benadryl about 36 hours after injection.  All symptoms resolved within 48 hours of injection.
9-28-17 0800 most of upper arm is red, puffy and warm. 9-28-17 9:30 PM arm is warm this evening, increased red, puffy, warm. 9-29-17 9:00 PM arm is much better this PM. 10-1-17 10:22 AM a tiny bit of redness last night. No meds. No treatment.
15 hours later developed fever up to 101, chills, muscle pain throughout body, headache,  sweating, and joint pain. All gradually subsided by 72 hrs except fatigue did not subside. At 96 hours after vaccine i developed hives in several different areas on my body. Some itched, some did not.
She is highly allergic to the Pfizer covid-19 vaccine; Itchy patchy rash on that resembled shingles on her back, higher thighs, and shoulders; Itchy patchy rash on that resembled shingles on her back, higher thighs, and shoulders; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 73-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 02Mar2021 (at the age of 73-years-old) as 1ST dose, single for COVID-19 immunisation. Medical history included poliomyelitis (haven't had a shot since polio). The patient's concomitant medications were not reported. On an unknown date in Mar2021, the patient was highly allergic to the Pfizer COVID-19 vaccine, had itchy patchy rash that resembled shingles on her back, higher thighs and shoulders. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 11-SEP-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB 10 mcg/1 ml "10X1 DS/V TF" with lot number K002327 with expiration date of 07-FEB-2016 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 34 F (1.111111111 Celsius). The sumo of hours in excursion was 96 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Resident rec'd Pfizer Biontech bivalent on 6/8/23 on 6/11/23 resident developed moderate amount swelling at inject site with some warmth, denies pain, resident had no c/o until 6/11 and reported to this nurse today that this happens with every vaccine I have rec'd all the way back to being a child. I reminded her that she told me prior to vaccination that she has "no problems" and she said she guess she forgot to mention that. She reports none of the previous episodes were treated with abx and they just resolve. Swelling is better today she reports and denies pain, slight warmth, resolving, seen by PCP and will continue to monitor
No additional AE/PQC was reported; she and her husband received a single dose of PENUMOVAX 23 approximately 6 years ago and were told they needed to receive a second dose, 5 years after receiving the first dose; This spontaneous report was received from a the patient's wife regarding a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      In approximately August 2015 (reported as 6 years ago), the patient was vaccinated with a single dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and the expiration date) for prophylaxis.         He would need to receive a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 5 years after receiving the first dose (approximately in 2020). Caller confirmed her husband had not received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) yet (inappropriate schedule of product administration).   This is one of two cases reporter by the same consumer. Marrs# 2108USA006307.; Sender's Comments:  US-009507513-2108USA006307:
p/vax pt exp fever, vomiting & screaming synd p/vax;
10/8/21 noticed that there was a red circle about 3 inches wide  by the injection site and it was hot to touch and a little itchy.  Called doctor and she asked me to come in to office to  look at it.  She said is was a skin infection.  Doctor gave me a perscription for Doxycycline 100mg- 1 tablet twice a day for 7 days and use ice for the warmth.   Spot started to clear up after about 3 days.      The same thing happened when I got the Shingles and Pneumonia vaccines.  I just have sensitive skin.
Allergic to flu shot I end  up in the hospital; This case was reported by a other health professional via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction (serious criteria hospitalization). On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The patient was going on 67 years at the time of reporting. The age at vaccination was not reported. The patient had not had chicken pox. The patient was allergic to flu shot and ended up in the hospital. After three years the patient was ok and thought she should take Shingrix or zoster vaccine. The reporter consented to follow up.
LUPUS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 patient experienced lupus and it was reported as "I had the J&J shot and here I am a year later diagnosed with Lupus.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221260119- Lupus. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
With the first one she didn't feel good, low grade fever and aches and pains; With the first one she didn't feel good, low grade fever and aches and pains; States that with each dose the symptoms were worse than the one before and this last one she was in the ER; diagnosed with costochondritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 at 15:00 as dose 1, single (Lot number: EN9581), in right arm, on 04Mar2021 at 15:00 as dose 2, single (Lot number: EN6199), in right arm and on 13Nov2021 at 19:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 63 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "breast cancer" (unspecified if ongoing), notes: Breast cancer diagnosed 12 years ago; "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); SINGULAIR taken for hypersensitivity; ROSUVASTATIN taken for blood cholesterol (ongoing); MONTELUKAST taken for hypersensitivity (ongoing); DYMISTA taken for hypersensitivity; AZELASTINE taken for hypersensitivity. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "With the first one she didn't feel good, low grade fever and aches and pains"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "States that with each dose the symptoms were worse than the one before and this last one she was in the ER"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "diagnosed with costochondritis". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of condition aggravated, costochondritis.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information: Amended the made case as valid. updated narrative information.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Jan2021 at 12:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Sep2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 02Jul2022 at 14:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: antigen testing became lighter positive daily; (11Aug2022) Negative, notes: negative on 1st day after completing paxlovid; (12Aug2022) Negative, notes: again negative 2 days after completing; (15Aug2022) Positive, notes: I again tested antigen test strongly positive that same day; (unspecified date) Positive, notes: I started paxlovid on day 2 after covid symptoms started and testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Rebound covid infection after completing paxlovid course. I started paxlovid on day 2 after covid symptoms started and testing positive. I felt better 24 hours after starting medication, antigen testing became lighter positive daily and negative on 1st day after completing paxlovid, again negative 2 days after completing. Return of symptoms occurred 5 days after completing paxlovid and i again tested antigen test strongly positive that same day. Now Day 2 after return of symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a causal association between the reported event and BNT162b2 cannot be excluded.
positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; This is a spontaneous report from a Pfizer-sponsored program from a contactable physician (patient).  A 56-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1284), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient had a PCR test on 12Jan2021 and was COVID-19 positive, asymptomatic. The patient had a rapid test on 14Jan2021 and came out negative. The doctor was asking if he can be able to get the second vaccine a longer than 3 weeks which is in the 6th week, asking if it could make a difference since he was tested positive. The outcome of the events was recovered on 14Jan2021.; Sender's Comments: The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 30Dec2020, and a PCR COVID-19 test positive on 12Jan2021, asymptomatic. No complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information is needed for a full meaningful medical assessment.
Cellulitis of right upper arm, treated with BACTRIM DS 800/160mg x 7 days.
INJECTION SITE PAIN; TIRED; SLEEPINESS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 65 year old. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805022 expiry: 25/MAY/2021) .5 ml, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced injection site pain. On 06-MAR-2021, the patient experienced tired. On 06-MAR-2021, the patient experienced sleepiness. On 06-MAR-2021, the patient experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 06-MAR-2021, and tired, sleepiness, and flu-like symptoms on 11-MAR-2021. This report was non-serious.
7 days after injection,  I developed discomfort to injection site accompanied by rash, redness, itching and warmth to touch.  It started about 2 cm and grew to 10x12 cm area within 2 days with blanching to the center region at injection point.
Right thigh became red & raised round red circle size of quarter. No fever - Started 24/hrs after shots looked worse 9/23/2010. Dr suggested treatment BENADRYL. Local reaction s/s Dx.
I woke up at midnight with blisters all over my tongue and was having a hard time talking. Fever of 101, sore throat and tired. All my symptoms were gone Wednesday night.
Pain at the injection site; malaise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were recovered/resolved.   It was unknown if the reporter considered the injection site pain and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient after receiving 2nd dose of Shingrix he experienced pain at the injection site and malaise for 3 days.  No additional information provided. The reporter consent to follow up. This case has been linked with case US2020186287reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020186287:same reporter
Asthma exacerbation with new oxygen requirement in the setting of a triggering event, such as: Covid
Nickel-sized raised patch in left arm adjacent and inferior to injection site after MMRV injection. Child observed in clinic for 10-15 minutes after reaction. No new rash, no change in rash and no respiratory problem noted.
Nauseated and lightheaded, near syncope.  Lasted about 20 minutes, took vitals, rested, and recovered.
MMRV given SQ in (L) arm 3/11/19, increased redness and swelling at injection site noticed approximately 24 hours later, developed fever at 24 hours. Today approx 3 inch erythematous, warm, swollen area around injection site, very tender to touch.