chrisvoncsefalvay/vaers-outcomes huggingface dataset:
it was blotchy and turned red; it was blotchy and turned red; the area started to itch; soreness and warmth at the injections site; soreness and warmth at the injections site; This is a spontaneous report from a contactable nurse (patient) via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Feb2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced soreness and warmth at the injections site on 20Feb2021, the area started to itch on 22Feb2021, and it was blotchy and turned red on 01Mar2021. Patient reported that she experienced soreness and warmth at the injections site. Two days later the area started to itch, but she didn't bother with it, 9 days in and she rubbed the area but still didn't itch it, the whole are became red. And when it subsided, it left a blotch, with off and on itching. Patient reported that the blotch is really mild, it was fading, but it leaves her feeling uncertain. Outcome of event soreness and warmth at the injections site was unknown, the area started to itch was not resolved, Blotchy was resolving and Redness was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
It was reported that an 18 year old male pt received a Menomune vaccination on 01/16/2002. Reportedly on 04/21/2002 the pt was diagnosed with meningitis. From follow up correspondence received on 4/24/02 via telephone it was reported that the pt received his Menomune vaccination a different state. The lot number provided was UB093AA. On 4/20/02 the pt developed a fever, sore throat and a very severe headache. On 4/21/02 the pt was seen in ER with a rash. CSF confirmed diagnosis of group C meningitis. Linked cases: U2002-00243 and U2002-00295 From telephone correspondence received at manufacturer on 4/29/02 the lot numbers are either UB0093AA (a yellow fever diluent as per regulatory affairs) or UB0095AA. They received Menomune, MMR, Tet booster, IPV, YF and Hepatitis. All three cases are considered recovered. Follow up telephone contact to doctor on 7/23/02: doctor stated that the name under form completed by was incorrect; it should have been a different doctor for that location. However, he was able to confirm that no more information is available and the information on the form is correct. Case closed.
"tired feeling"; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE ("tired feeling") 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 FATIGUE ("tired feeling"). At the time of the report, FATIGUE ("tired feeling") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications was not given.
Arm hurts; This is a spontaneous report from a program reported by the consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm hurts. The patient reported that took a second shot. Does it make a difference with stronger reaction, Arm hurts. Hearing nightmares about second shot. Outcome of the event was unknown.    No follow-up attempts are needed, information about lot/batch number cannot be obtained
This spontaneous report was received from a physician via a company representative refers to a 62 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in 2014 (reported as about 1 year ago) the patient was vaccinated with ZOSTAVAX (Lot# not reported). On an unknown date, the patient experienced outbreak of shingles in the abdominal region, while on therapy with ZOSTAVAX. The patient did not take any treatment medication for the event. The patient went to the physician on an unspecified date for medical attention. The outcome of herpes zoster was reported as recovering. The reproter did not provide the relatedness of event with ZOSTAVAX. Additional information is not expected as the reporter did not wish to be contacted.
The pain is the worst I've ever experienced in all my 75 yrs and it is still continuing 12 days later, and w/pain relievers to no avail. Can't sleep, sit, rest, etc. No end in sight. I will not get the 2nd shot! If I had been told it would be so unbelievably painful for so long, I never would have gotten it. Still have the rash too. One finger went numb and has not returned to normal. Shoulder blade and armpit pain too.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 16th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
07/19: Vaccines given. 07/20: LGF, screaming. 07/21: "Terrible", screaming. 07/22: Office visit (enclosed). 07/23: Daytime-better; Nighttime-fever began (102-102 rectally). 07/25: No fever, slept thru night. 07/26: Fever returns. 07/27: Office visit (enclosed). 07/28: Symptoms resolved. 08/12: Doing fine!
Patient came in for PPD (purified protein derivative) read.  Left deltoid about one and a half times the size of right deltoid, positive redness, positive warmth, positive pain. temperature 99.6 F axillary. Sent to hospital emergency room for evaluation.
Tingling in  hands and feet and weaknesses in hands and feet. Problems climbing my stairs.  Difficulty walking severe back pain vomiting due to pain. Hospitalization.
Noted reddened area around site of injection & hardened area 10 mm site of injection.
injection site red and spreading; injection site itching that is spreading; injection site hot; injection site itchy; injection site red; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE PRURITUS (injection site itchy), ERYTHEMA (injection site red and spreading) and PRURITUS (injection site itching that is spreading) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE WARMTH (injection site hot) and VACCINATION SITE PRURITUS (injection site itchy). On 01-Feb-2021, the patient experienced ERYTHEMA (injection site red and spreading) and PRURITUS (injection site itching that is spreading). At the time of the report, VACCINATION SITE ERYTHEMA (injection site red), VACCINATION SITE WARMTH (injection site hot) and VACCINATION SITE PRURITUS (injection site itchy) had resolved and ERYTHEMA (injection site red and spreading) and PRURITUS (injection site itching that is spreading) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Patient called back to report, initial delayed reaction went away, but came back on 01Feb2021 again and is spreading., vaccine lot NO. was added.
Severe topical reaction; This case was reported by a pharmacist via sales rep and described the occurrence of skin reaction in an unspecified number of  patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent .5 ml. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to FluLaval Quadrivalent.  Additional details were provided as follows: This case was reported by the reporter for his or her prisons employees. The age at vaccination was not reported. The reporter stated that the patients had severe topical reactions to FluLaval. This is 1 of the 2 cases reported by the same reporter.
12/17 /22 I felt like I was coming down with a cold. I had nasal congestion and cough Symptoms gradually progressed and by 12/20/22 I could not get out of bed. I reached out to my Physician via a telehealth visit. I was told it was too late to start Paxlovid since it has to be taken at the onset of COVID-19 symptoms.  Symptoms lasted 3-4  days later.
Information has been received from a physician, via a company representative, concerning a 12 year old female patient, who on an unknown date was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included Menactra and M-M-R II (MSD). Following vaccination with Gardasil, the patient felt dizzy, had tightness in her throat, felt warm, and "fainted for a second." Subsequently, the patient recovered from the events (duration not specified). The patient sought unspecified medical attention. Additional information has been requested. This is a follow-up to report (s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician concering a 12 year old female student, with no pre-existing medical conditions, who on 20-Jun-2007 at 2:00 pm, was vaccinated IM in the left deltoid, with the first dose of GARDASIL (lot # 654510/0962F). Secondary suspect therapy included the firse dose, IM in the right deltoid of BOOSTRIX (Lot # AC52B014AA), and the first dose, IM in the right deltoid, of GARDASIL (Lot # AHBVB319AA) (previously reported as including MENECTRA and MMRII. There was no illness at the time of vaccination. At 2:06 pm, "after given shot." the patient felt dizzy, had tightness in her throat, felt warm, and briefly fainted. She felt clammy and was sweating when she awoke 2 - 3 minutes after, and stated she "felt funny" for approximately 5 - 10 minutes. She was evaluated in the clinic for 45 minutes, then denied any symptoms. Additional information is not reported.
ery red on the arm and that cannot move it and cannot lift it; trouble breathing; very red on the arm and that cannot move it and cannot lift it; Fever; lots of head ache; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (ery red on the arm and that cannot move it and cannot lift it), DYSPNOEA (trouble breathing), INJECTION SITE ERYTHEMA (very red on the arm and that cannot move it and cannot lift it), PYREXIA (Fever) and HEADACHE (lots of head ache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTED LIMB MOBILITY DECREASED (ery red on the arm and that cannot move it and cannot lift it), DYSPNOEA (trouble breathing), INJECTION SITE ERYTHEMA (very red on the arm and that cannot move it and cannot lift it), PYREXIA (Fever), HEADACHE (lots of head ache) and VOMITING (vomiting). At the time of the report, INJECTED LIMB MOBILITY DECREASED (ery red on the arm and that cannot move it and cannot lift it), DYSPNOEA (trouble breathing), INJECTION SITE ERYTHEMA (very red on the arm and that cannot move it and cannot lift it), PYREXIA (Fever), HEADACHE (lots of head ache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment reported. no concomitant medication reported. Upon in internal review on 20 May 2021, the age was corrected to 18 years
Diarrhea; Nausea; This is a spontaneous report from non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EVV0153) via an unspecified route of administration in the arm left on 13Apr2021 at 15:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The medical history included ehlers danlos hyper mobile type, postural orthostatic tachycardia syndrome (POTS). 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 COVID-19 vaccine. The concomitant medications included pregabalin (MANUFACTURER UNKNOWN), Ondansetron hydrochloride (ZOFRAN), ibuprofen (ADVIL), ivabradine hydrochloride (CORLANOR) and codeine phosphate, paracetamol (TYLENOL WITH CODEINE NO 3), all for an unknown indications from an unknown dates and unknown if ongoing. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 21Mar2021 at 16:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient also received previously desogestrel/ethinylestradiol(RECLIPSEN) and amoxicillin/ clavulanate acid(AUGMENTIN) and experienced allergy. On 14Apr2021 at 10:30, the patient experienced diarrhea and nausea. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea and nausea was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt devel inject site rxn of swelling,erythema after vax. This pt has had inject of flu vax each of the past few yr. This is 1 of 6 elderly pts who devel inject site rxn.
Minor previously received 1st dose in HC on 6/2/22 and second dose of vaccine on 11/7/22. Minor received a third dose on 12/7/2022. No adverse reaction
pt recv vax 20NOV95 & 22JAN97 pt antibody titer results were equivocal & 10MAY97 pt antibody titer results indicated pt was non-immune;
Sudden chills and fatigue; Sudden chills and fatigue; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0158) via an unspecified route of administration on 10Apr2021 at 09:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccine within four weeks prior to the vaccination. The patient's concomitant medications included tetanus vaccine(MANUFACTURER UNKNOWN), levothyroxine sodium (UNITHROID), bupropion hydrochloride (WELLBUTRIN) and duloxetine hydrochloride (CYMBALTA), all from unknown dates and for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP7543) via an unspecified route of administration on 20Mar2021 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced sudden chills and fatigue which were not constant, the patient would get chills and be tired. The patient was concerned because the events was continued past 1 week mark. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department/urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sudden chills and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Redness; Swelling; This case was reported by a other health professional via sales rep and described the occurrence of erythema in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved.   It was unknown if the reporter considered the erythema and swelling to be related to FluLaval Quadrivalent.  Additional case details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, there were several patients who had redness and swelling for several days after administration of flu vaccination. The reporter consented to follow up. This case has been linked to US2019AMR176811, reported by the same reporter.
Headache, Myalgia, Arthralgia,  sore left arm; Narrative:  1st vaccination 12/22 - sore arm and mild headache 2nd vaccination 1/12 - soreness at the injection site, ache in her hip and headache. Symptoms relieved by tylenol. Resolution of symptoms 12/14
any minor aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (any minor aches) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (any minor aches). At the time of the report, PAIN (any minor aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient enquired whether ibuprofen can be used for minor aches. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
4FEB94 pt very tired in school; 5FEB93 mom noted excessive thrist & freq urination; 10FEB94 seen by MD sent to hosp bl sugar done-573 @ hosp blood also drawn for coxsackie virus;
Patient began to feel very hot, skin became very red on chest and face and sudden headache app. 15min after administration of vaccine. Patient was sitting, alert and oriented. Teary eyed. Offered water to drink and cold cloth. Began to feel better. Monitored for additional time and left clinic feeling better app. 50 min after administration.
Had vaccine on 12/24 and red, warm at injection site size of golf ball.  Going to Occ Health for evaluation
Day 1. Fever and shaking chills. Strong body pain.  Treatment: Equate NiteTime and  DayTime Cold & Flu, Naproxen 500mg.                                                           Day 2 to present. Diarrhea, heartburn, bitter taste, stomachache, thirsty, body pain. Treatment: Pepto bismol.
Four days after receiving Tdap, RABAVERT #1, HAVRIX #2 and Hep B #3, patient developed a generalized rash (red, raised tiny bumps) on both arms and torso. Rash very itchy, no fever or angioedema.
spells of dizziness after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "spells of dizziness after the first dose".  Additional information: I took the first two doses of the covid 19 vaccination, as recommended. I had spells of dizziness after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red, tender area around inj site with reticular pattern and few ruptured and new vesicle and bullae. Keflex 500mg tid po x 10 days.
two bumps behind his ear; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated that the patient broke out with two bumps behind his ear after receiving the Shingrix vaccine. The reporter was unwilling to provide any additional details.
Narrative:  Syringe was drawn up from the vial on 6/1, 0.5 ml. It was not utilized or disposed of on 6/1 as would be appropriate for a 12 hour BUD. Since it was not disposed of per procedure and left in the vaccine prep area, the 6/2 staff did note the 6/1 date and utilized this syringe to split and make two 0.25 ml booster vaccine doses. These were administered. No adverse outcome identified.
Developed macular papular rash with pruritis on left arm near injection site 4 days after receiving ZOSTAVAX, spread over entire body in 24 hrs.  I saw her 48 hrs after rash onset.