chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; the patient was given a dose of VAXNUEVANCE after the dose was stored improperly; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 05-MAY-2023, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5ml/ series, lot #W027275, expiration date: 09-JUL-2024, administered for prophylaxis (strength, and route of administration were not provided).  On 05-MAY-2023, HCP called to report the patient was given a dose of VAXNUEVANCE after the dose was stored improperly. TE case with the supported outcome is 02385439. Pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) was impropertly stored in 34 F degrees for 7 hours. No additional AE/PQC.
Adverse reaction to 1st Pfizer Covid dose injection. Have seen Dr & also had ultrasound of knots/clots underneath injection area. Injection site is still hard, sore & entire arm is numb from site down thru hand. Cannot use left arm without pain going all thru shoulder & neck. Still have painful knots underarm & on side of arm that was injected. Hair falling out in hugs handfuls. This is exactly one mths & 1 day from injection. On day of injection, started projectile vomiting within 2 hrs. Lasted over 5 hrs. Ran fever & chills & headache & severe pain on entire left side of rib cage for 11 days. Could not cough without pain in lungs. Breathing was very difficult & painful. Diarrhea on 9 - 11th day. Runny nose on 11th. Had 2 Covid tests done during all of this. Negative for Covid.
"63 yo female with 1 week h/o skin lesions as described below. Received 2nd SHINGRIX vaccine on 2/15. All symptoms have resolved except for rashes. Itchy lesion on L thigh, size of palm of hand. Also involved hand and 3 areas on face. No breathing difficulty or facial/throat swelling."
This spontaneous case, initially received on 24-Oct-2018, reported by other non-healthcare professional (consumer), concerns a female patient of an unspecified age. On an unspecified date in 2017 (reported as last year), the patient was administered Influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On an unspecified date in 2017, right after the vaccination, the patient experienced tightness in throat and had a very warm feeling that extended from her neck to her face. The patient told the pharmacist about it, and he instructed her to sit down in the waiting area. It was reported that the symptoms went away after sitting in the waiting area for several minutes (recovered). The patient had not taken any treatment measured for the events. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
Chills and fever along with dizziness, weakness, and joint pain started ~12 hours post vaccination lasting about 4-5 hours.  Persistent pain was treated with 200 mg ibuprofen 28 hours post vaccination.  48 hours post vaccination had mild nausea and fatigue.  All symptoms appeared resolved by 60 hours post vaccination.
Stomach ache; Itchy arm; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Mar2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021, the patient experienced stomach ache, itchy arm and chills. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach ache, itchy arm and chills were not recovered at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe body ache and inability to move arm due to severe pain, high fever over 102 degrees, experienced seizure type whole body jerking two times during evening of 6-18, continued pain throughout body and right arm even now 6-21-2010.
Pt developed Chest pressure 20 minutes post injection, BP was 150/90 Transported to medical center via Amb CAOx3
next day she had a fever the next day after taking the vax.  2 days later she had a 101 fever and she had severe pain shooting through her lower extremities.  she contacted a physician that is a friend and asked to for an order to start therapy.  On the 3rd day she started physical therapy.  She started getting worse so she contacted her surgeon that ordered an MRI.  DX is stenosis and bulging disc which she has had for years but has never been laid up because of it.  She went to her PCP. They feel like she developed inflammation of the nerves for the weak parts of her body after taking the vax.   The pain is in the nerve from her waist down to her ankle. She is still doing the physical therapy.  She is scheduled to see an Orthopedic Doctor on 4/23/2021.
pt recvd vax; devel inject site pain coincident w/ adm of vax;
Fatigue and dizziness, and a few days later, started that buzzing in my ears.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of Gardasil. After the patient received one dose of Gardasil she experienced numbness in her arm. Patient received vaccination from her primary care physician and not the reporting physician. The patient did seek unspecified medical attention. At the time of this report, the outcome was unknown. No product quality complaint was involved. Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a patient who received Rotavirus vaccine (batch number 35T34) for prophylaxis.   On 21-FEB-2023, the patient received Rotavirus vaccine. On an unknown date, an unknown time after receiving Rotavirus vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
This spontaneous report as received from a consumer refers to his wife, a 63 years old female patient. The patient had none pertinent medical history and none drug allergies. The patient was vaccinated with ZOSTAVAX (lot # reported as "H009779", expiration date March 2013) on 12-AUG-2012. Concomitant medications were reported as none. It was reported that a herpes break out developed on patient's arm after she received the ZOSTAVAX on 13-AUG-2012. The patient sought for medical attention via an office visit. And treatment was given by using antibiotics. The outcome was reported as not recovered. Additional information is not expected.
First dose was 44 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication use was provided by the reporter.  No treatment of events was reported.
DRYNESS AND SOUR TASTE IN MOUTH, CHILLS AND SORE THROAT.
Client was provided with Pfizer vaccine as 2nd dose of Moderna vaccine series. Client declined any adverse signs or symptoms.
Elevated heart rate one day after vaccine (2nd does only). Heart rate was around 100-110 as read by my watch while laying down/sitting. Normal resting HR is around ~60-65 beats a minute. Lasted about 8 hours before heart rate slowly started going down. Was okay the next day. Had other normal symptoms such as chills/fever , tired and overall did not feel good out of it.
Not feeling great; Fatigue; Nausea; Fever; 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 MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) 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 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever). At the time of the report, MALAISE (Not feeling great), FATIGUE (Fatigue), NAUSEA (Nausea) and PYREXIA (Fever) had not resolved.            No concomitant and treatment medications were reported.
18 hours post vaccine employee c/o redness and soreness with a low grade fever. Warmth at injection site.
lt pt in car p/receiving vax another child brought pt in to the store pt was red as a beet & druggist thought might be having a reac to vax; pt taken to ER color returned to nl by time seen by MD; no tx given; poss combination of vax & heat
Dizziness, felt faint, racing heart, elevated bp about 5- 10 minutes after being vaccinated. This subsided after 10 -15 minutes, but then recurred for a total of 4 times for shorter periods of over the next 90 minutes. Had headache, felt fatigue, chills and feverish later that night.Fatigue continued for next several days lessening over time, headache continued for next several days, lessening over time.Soreness at injection site for a couple of days, but no swelling or redness.
Hot to the touch, rash surrounding the site, firm knot, and bruising. Call patient to check on her- bruising still apparent but rash, firm knot went away, and still a little warm.
about 3 hours after injection i noticed i was flushed neck ears face, about 5 to 6 hours my ears started ringing, trouble sleeping legs pricing over night., 2 degrees elevated temperature from normal.  this lasted for almost exactly 24 hours. my leg pain is in the same location as a severe blue of shingles i had two years ago. it is now 96 hours after injection and my legs are still tingling and occasionally feel prickly and painful. this is manifesting into right toes. there is an odd numbness to my right thigh. i was worried somehow i might have triggered another shingles type outbreak.
Extreme Vertigo with vomiting lasting an hour. Then several hours later, another episode exactly the same on Day 12, March  16, 2021  Mini episodes lasting a minute or so with and without vomiting since.
fever;painful red lump @ inj site;irritability, rigidity;floppiness;disturbed sleep;vomiting;diarrhea;ice & DPH suggested;@ time there was also a flu like illness in town;
Sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12-JAN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK receipt date: 04-APR-2023 The patient herself reported this case.   The patient stated that she had her dose of Shingrix administered and she had a sore arm for a couple days. The reporter consented to follow up.
After having vaccines, pt. fell onto the floor, lost consciousness and had a possible seizure. Taken to E.R. for evaluation. Released and referred to neuro.
This spontaneous report was received from a nurse and refers to a female patient of unknown age with no drug reactions or allergies. The patient had no pertinent medical history. On 18-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 in the right arm for immunization (lot # M003659, expiration date: 20-SEP-2017; dose and route were not provided). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and an unspecified seasonal birth control pill. On an unknown date in 2016, the patient experienced hives and big bruise on her right arm. Hives occurred a few days after receiving GARDASIL 9 dose and extended from near injection site all the way down to her hand. The patient took BENADRYL for hives and the event subsided within a few days. No lab diagnostics studies were performed. The outcome of the events was reported as recovered on an unknown date in 2016. The patient did not seek medical attention. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
My arm started feeling sore almost right away, it got worse over the first day and then felt somewhat better April 7. Almost completely resolved by the morning of April 8. The evening of April 7, I started feeling some tingling in my face and in the left arm. There were also waves of coolness in my arm, neck, and back region. They are still happening the morning of April 8. Extenuating circumstances: I received word my mother fell and broke her hip the day of April 7, and my sisters and I were discussing options for her treatment around the tingling started.
Approximately 10 hours after receiving the second vaccination I started feeling fatigued and achy. About four hours after that I began having chills and ran a fever around 101. I took 1000 mg of Tylenol about 19 hours after receiving the injection and it helped bring the fever down to low 99?s and got rid of the chills. It did not help the aching at all so about three hours after that I took 600 mg of Motrin.  It is now 41 hours after the injection and I?m still a little achey, but overall feeling better.
Patient began to feel dizzy and hot. She then regurgitated. She claimed she felt better afterwards.
Patient received the updated booster vaccination and 3-4 days later began experiencing heart palpitations/ rapid heart rate. He reported to his primary care physician where it was discovered that he had a heart arrhythmia. Patient has since been referred to a cardiologist for further care.
Information has been received from a pharmacist concerning a 65 year old female who on 06-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) in her left arm (lot# not reported) and experienced an injection site reaction. In the evening of 06-JAN-2009 the patient's injection site was red and warm. The pharmacist instructed the patient to take BENADRYL which she did. On 07-JAN-2009 the patient woke up and had redness and swelling down to her elbow and up to her neck. She saw her physician on 07-JAN-2009 who prescribed LEVAQUIN and FLAGYL. On 09-JAN-2009 the patient called the pharmacist to say her arm was blistered around the injection site and she was still taking LEVAQUIN and FLAGYL. She reported her arm felt better. The outcomes of the redness, warmth, swelling and blisters were unknown. Follow-up information from a physician who reported he had no information on this case because the patient was not given vaccine or seen in his office for treatment following vaccination of ZOSTAVAX. No further information is available.
menstrual cramps but no period; Exhaustion; nausea; headache for 3 days after 1st dose; 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), administered in arm left, administration date 28Mar2021 (Lot number: ER877) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "bipolar type 2" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin,. Concomitant medication(s) included: ZYPREXA; LAMICTAL; OTREXUP; CELEBREX; B12 [CYANOCOBALAMIN]; D3. Past drug history included: Erythromycin, reaction(s): "Known allergies:erythromycin", notes: Known allergies:erythromycin; Zithromax, reaction(s): "Known allergies:Zithromax", notes: Known allergies:Zithromax; Vancomycin, reaction(s): "Known allergies: Vancomycin", notes: Known allergies:vancomycin; Duracef, reaction(s): "Known allergies:Duracef", notes: Known allergies:duracef; Darvocet, reaction(s): "Known allergies:Darvocet", notes: Known allergies:darvoset; Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies:amoxicillin. The following information was reported: DYSMENORRHOEA (non-serious) with onset 28Mar2021, outcome "recovered", described as "menstrual cramps but no period"; FATIGUE (non-serious) with onset 28Mar2021, outcome "recovered", described as "Exhaustion"; NAUSEA (non-serious) with onset 28Mar2021, outcome "recovered", described as "nausea"; HEADACHE (non-serious) with onset 28Mar2021, outcome "recovered" (31Mar2021), described as "headache for 3 days after 1st dose". Therapeutic measures were not taken as a result of dysmenorrhoea, fatigue, nausea, headache.  Additional information: The patient did not received any other vaccine in four weeks. The patient did not had covid prior vaccination and not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from a consumer regarding a male patient who experienced autism. The patient received the fourth dose in 1999. Additional suspect vaccines included Prevnar, and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered in 1999. Dose regimen was 1 dose 1 time per day. Additional suspect vaccines included Prevnar and Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine. Concomitant medications were not reported. The patient's mother reported that her son developed autism. The date was not specified. Recovery status is unknown. No additional information was available at the time of this report.
rectal abscess; this time it worsened; I was in pain; high fever; This is a spontaneous report received from a contactable consumer (patient). A 60-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171) via an unspecified route of administration on 27Apr2021 at 18:15 (at 60-year-old), as dose 2, single for COVID-19 immunization. The medical history of the patient included amoxicilin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. It was mentioned that patient was not diagnosed with COVID-19 prior to vaccination and patient had not been tested for COVID-19 since the vaccination. On 10Apr2021 at 07:00 the patient had rectal abscess which started 3 days after the first jab. It peaked in 10 days and without the surgery and disappeared in about 17-18 days. The abscess returned 3 days after the second jab on an unspecified date in Apr2021 and this time it worsened and required Surgery as treatment to get rid of. The patient was in pain and high fever for several days on an unspecified date in Apr2021. Therapeutic measures were taken as a result of events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information had been requested
A pediatric dose was ordered (for the pediatric patient) but an adult product (Hep A)  was chosen and administered without lot numbers being verified. This particular patient was an adolescent, so the higher dose won't necessarily result in harm. No adverse symptoms occurred.
4 months  after injection my arm and shoulder are in  pain.  Cannot lift shoulder to get undressed.  Cannot sleep due to pain at injection site.
Redness, warmth, induration + 10mm., soreness. No temp. Tx: Prednisone 40 mg STAT. May apply ice as tolerated. Hydrocortisone cr. BID. BENADRYL 50 mg QHS x 3 nights.
1. Chest Pain - Intermittent episodes of chest pain for 4 weeks after vaccine 2. Axillary lymph node swelling after the vaccine - resolved within a few weeks
20 hours after shot, persistent fever maintained at 102.7 while covered by Tylenol 1 gram and Motrin 800 mg being taken every 6 hours. Severe chills, shaking, body soreness, and fatigue.  Left Arm swelling, redness the size of a softball, hard and hot skin.  Arm swelling lasted for 6 days.
Onset:  1 day later:  red ears and hands, swollen hands.  interrupting sleep and decreased appetite.  seen at urgent care and ER.  Rx'd antihistamines Benadryl and Claritin, topical triamcinolone, and Tylenol, didn't help.  7/3/2023 I rx'd prednisone 40mg for 5d (but stopped it after 2d since didn't seem to help and I was worried about triggering delirium), aloe, and cool compresses.  They tried gold bond powder and aleve.  I added aspercream. They told me whenever he went near heat the hands and ears would get red and swollen again and it progressed through the day.  2 weeks later noted gets worse as soon as sun comes up.  I recommended they try to see dermatology through clinic since there's a long wait otherwise.  I also recommended cotton gloves or the kind impregnated with aloe esp if sits on the porch in the sun.  (since also on doxycycline for LYME).  7/20/2023 wife requested "labs to see if anything else going on".  I ordered a CBC and CRP.  Essentially normal but sl elev abs N's (8554 cells/uL where normal was up to 7800) with normal %N's.  Wife called again today 8/2/2023 stating patient's hands are swollen (still?  again?) so I referred to Immunology.    I am suspicious about the Lyme dis affect on his immune system in the setting of melanoma and the doxycycline RX for 1months with sun exposure possibly causing photodermatitis so I thought once the doxycycline was out of his system for a week he'd improve.  But he has not improved.