chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache began at 1:00 PM same day after receiving vaccine, with arm pain for 2 days. Unexpected menstruation on 1/6/2021, with intense menstrual pain more than  experienced before.
Received vaccine under 18 years old; A spontaneous report was received from a pharmacist for a female patient under 18 years of age who received Moderna's COVID-19 vaccine (mRNA-1273). No adverse event was reported after the administration of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 01 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment information was not applicable.  Action taken with mRNA-1273 was unknown.  The outcome of the event, received vaccine under 18 years old, was recovered.; Reporter's Comments: This case concerns a female patient under 18 year-old who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
her arm blew up with edema (moderate); Hives; likely experienced an allergic reaction; arm itching; arm redness; typical arm pain; arm  swelling; Chills; Fatigue; a swollen lymph node on same side of injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic urticaria (18 years ago). Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, VALACYCLOVIR [VALACICLOVIR], ALPRAZOLAM (XANAX) and VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site). On 14-Jan-2021, the patient experienced OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives), HYPERSENSITIVITY (likely experienced an allergic reaction), PRURITUS (arm itching) and ERYTHEMA (arm redness). On 09-Jan-2021, VACCINATION SITE PAIN (typical arm pain), VACCINATION SITE SWELLING (arm  swelling), CHILLS (Chills), FATIGUE (Fatigue) and LYMPHADENOPATHY (a swollen lymph node on same side of injection site) had resolved. At the time of the report, OEDEMA PERIPHERAL (her arm blew up with edema (moderate)), URTICARIA (Hives) and HYPERSENSITIVITY (likely experienced an allergic reaction) outcome was unknown and PRURITUS (arm itching) and ERYTHEMA (arm redness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included Benadryl and Tylenol. Primary health care professional suggested diphenhydramine hydrochloride and paracetamol as treatment. The doctor stated that is likely an allergic reaction. It was reported that the events began to improve; but was still experiencing a red, itchy arm that is painful, but the events are "going down".   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Email address updated
RE: COVID 19 vaccine Reaction 2-15-21   After receiving the Pfizer covid 19, dose 1, patient was having trouble breathing as she exited the clinic room.  Outside the room patient was not able to get a breath, her escort kept her upright and called for help.  Patient was moved into a wheelchair.  I was called to assist.  The patient had provided an epipen and felt her throat was closing.  At this time, approximately 1350 I administered the Epipen.  Shortly thereafter the patient was able to get air again.  Her vitals were monitored for the next ~45 minutes and she progressively felt better. At this time the patient was offered and ER evaluation, but felt she was well enough to go home.  She was transported by her husband and instructed to follow up with her PCP regarding the 2nd dose.  I provided her with an epipen from our Emergency kit, as she did not have another one with her or at home.   Vitals  1350 BP 169/74 HR 65 O2 97%   1400 BP 175/69 HR 64 O2 97%   1410 BP 156/68 HR 72 O2 83%   1420 168/63 HR 63 O2 97%
- Itching, redness, and swelling to site started 2 days after vaccine lasted 4 days. - Headache 2 days: Treatment TYLENOL.
SORE ARM; HEADACHE; SORENESS AT AROUND INJECTION SITE; This spontaneous report received from a patient concerned a 36 year old female. The patient's weight was 140 pounds, and height was 65 inches. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-MAY-2021, the subject experienced sore arm. On 12-MAY-2021, the subject experienced headache. On 12-MAY-2021, the subject experienced soreness at around injection site.  Treatment medications (dates unspecified) included: Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, was recovering from sore arm, and the outcome of soreness at around injection site was not reported. This report was non-serious.
3YO received Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z1A024M, expiry date 17-FEB-2024) for prophylaxis.   Previously administered products included Pediarix (1st dose received on 25th September 2019), Pediarix (2nd dose received on 26th November 2019), Pediarix (3rd dose received on 6th February 2020) and Dtap (received on 28th October 2020).   On 06-OCT-2022, the patient received Kinrix. On 06-OCT-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3YO received Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAR-2023  The medical assistant (MA) enquired on how to proceed with the Kinrix series when the patient turned 4 years old. Kinrix was the 5 dose of DTap and 4th dose of IPV. A 3 year 2 month old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Achy upper arms - worse in left.  Feels like arms weigh more.  Went to doctor to rule out heart problems.  No heart problem found.
Hives all over my body starting at my arms now all over my stomach and legs. Seems to be getting worse everyday. Taking benadryl and zytrc to help with it.  I am very worried please help someone check this for me. I do not have insurance and really want to get this checked and cured. I never had any issues like this before thr vaccine. Please help me I am really worried about this.
pt recvd DTP/HIB/OPV & exp diarrhea for approx 1 month;  @ 4mos of age pt recvd DTP/HIB/OPV & 2 days later began exp diarrhea which is still persisting 1 wk later;
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L019297 with expiration 18-AUG-2017; lot# L020015 with expiration 16-AUG-2017; lot # L013429 with expiration 21-JUL-2017; lot# L000610 with expiration 31-JAN-2017, dose and route were not reported). The vaccines were exposed to two excursions: 9.8 centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report as received from a healthcare student refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL in March 2011 and the second dose in November 2011 and the third dose on 26-OCT-2012. Lot numbers of the vaccines were not reported. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The outcome of the patient was unknown. Additional information has been requested.
I95.9 HYPOTENSION 3/24/2023 DM 2 W HYPERGLYCEMIA I95.9 HYPOTENSION 3/24/2023 ORTHOSTATIC HYPOTENSION
LOSS OF BALANCE FOR SEVERAL DAYS;  NO PREVIOUS SUCH ISSUE, WITH OFF AND ON BALANCE ISSUES NOW SINCE OCTOBER 2019.  NO PARTICULAR PATTERN, JUST OCCURS WITHOUT NOTICE.
The day after the first shot, I felt the normal symptoms very sore arm, headache, lightheaded, and achy. The lightheaded feeling continued off and on for at least nine days or more and so did my very mild headaches. On April 9th I noticed that I had a red splotch at the injection site and that my arm, shoulder and neck were still sore. I called the pharmacy and they advised me to start benydryl which I took for two days and the blotch went away. The areas mentioned are still slightly sore but overall I am feeling better.
Red rash the size of a quarter surrounding injection site. Began early am 2 days after injection was given. Pt was advised to apply cold compress to site for 15 minutes, monitor, and call back with any further concerns.
10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; 10 days after COVID VACCINE had soreness, itching, warmth and red area size of orange at injection site on right arm; This is a spontaneous report from a contactable nurse (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot: EM9810 Expiration date:unknown) first dose intramuscular on right arm on 05Feb2021 08:30 AM (at age of 81-year-old) at single dose for Covid-19 immunization. Medical history included emphysema, ruptured eardrum partial deafness, arthritis from unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient has not tested COVID post vaccination. No other vaccine was taken in four weeks. Patient was allergic to Zyban. Concomitant medications included ASA 81 mg, MVI, Biotin, Vitamin C, Stiolto inhaler from unspecified date and unknown if ongoing. Patient previously 18 months ago got surgical glue in vein procedure,10 days later patient experienced warmth, redness, itching, tenderness at site after COVID VACCINE had soreness, itching, warmth, and red area size of orange at injection site on right arm on 13 Feb2021. No treatment received for the adverse event and the patient asked should I take the second dose of the vaccine. The outcome of events were recovering.
(1) (R) arm erythema/ed. (2) Fevers/chill. (3) Leth. (4) Mya.
Little Dizzines; Headache; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (Little Dizzines) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), ATORVASTATIN CALCIUM (LIPITOR), ALENDRONATE SODIUM (FOSAMAX), LEVOTHYROXINE, CALCIUM CITRATE, COLECALCIFEROL (CITRACAL + D [CALCIUM CITRATE;COLECALCIFEROL]), BIOTIN, ACETYLSALICYLIC ACID (ASPIRIN LOW), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication, LISINOPRIL.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced DIZZINESS (Little Dizzines) and HEADACHE (Headache). At the time of the report, DIZZINESS (Little Dizzines) and HEADACHE (Headache) outcome was unknown.        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 treatment information was provided.
Mom called at 09:00 and stated that pt had high fever, swollen mouth and tongue. Referred to ER and asked to call and let us know how she is. On 4/3/00, called client. MD at ER dx'd a sinus infection. Client states now better.
Experiencing severe pain in upper rotator cuff area and shoulder. Pain radiating down arm and creating numbness in arm and hand. Unable to move arm in certain directions or bear any weight. Unable to sleep through the night because of pain and no comfortable position. Was seen in Urgent Care and told to try heat, ice, 600-800mg Ibuprofen, Hydrocodone for pain control, none of which is helping. Schedule to seen pain management specialist on 11/11/14.
Pt informed me today 8-8-19, after vaccination she had a high fever that she couldn't control and was hospitalized for 3 days. The drs told her not to get anymore vaccines.
Patient had fever on 2/21-2/23; experienced febrile seizure x 2 on 2/23/15. Pt evaluated at ER on 2/23.
6-7 hours after inoculation, I developed fatigue and mild body aches.  15 hours after inoculation, I developed shaking chills then sweats (felt too unwell to go get thermometer to see if febrile). 24 hours after inoculation, still having body aches, chills (no more rigors/shaking chills), mild nausea, mild headache, mild back and neck pain, and fatigue.
Increased mood instability; paranoia; This is a spontaneous report from a contactable consumer. A 29-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Mar2021 11:00 (At the age of 29-year-old) as SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included bipolar disorder, anxiety, post-traumatic stress disorder. Concomitant medication(s) included Effexor, Lamictal, abilify, trazodone. Allergies to medications, food, or other products: Sulfa drugs. On 29Mar2021 15:00 the patient experienced increased mood instability, paranoia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has not tested for COVID-19, Since the vaccination. No treatment received. The seriousness was reported non-serious. The outcome of event was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
PT WAS GIVEN MODERNA VACCINE. PHARMACIST, AFTERWARD, REALIZED THAT PT WAS NOT ELIGIBLE FOR VACCINE DUE TO HIS AGE OF 17 YEARS.
Injection site pain; not sleeping; it still hurts, it is very sore by his bicep; sheer exhaustion; is very uncomfortable sitting; This is a spontaneous report from a contactable consumer reporting for himself. A 67-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1686, Expiry date: 31Mar2021), via an unspecified route of administration (arm left) on 18Jan2021, 12:00 (noon) at SINGLE DOSE for COVID-19 immunization, at 67 years old. Medical history included torn rotator cuffs from an unspecified date. The patient previously took Flu shot for immunization. Patient stated his last vaccination he had was the flu shot 6 months before on an unspecified date, that was a while back. Patient had pain in his left arm at the injection site. He is not sleeping because the pain is waking him up. It has been more than a week at 10 days, and it still hurts. It is very sore by his bicep. Events occurred on 19Jan2021, reported as started hurting the next day maybe, it was not immediately after. He says since then he has had pain, and in the past, he has had torn rotator cuffs, and those hurt, but he was not sleeping due to this pain now, he fell asleep at 06:00AM this morning from sheer exhaustion (Jan2021). He says he is very uncomfortable sitting, he can't lay on that side, and he can't get comfortable. He was taking MOTRIN 800 mg as needed, and he put ASPERCREME on it. He says that his MOTRIN was prescribed by a doctor, it was the only thing working for the pain for this. He says he also tried Naproxen, then says it's Aleve actually, he has only taken this once. It was 220 mg, he took one by mouth, one time. He applied the ASPERCREME to the injection site about three times last week, he says he was experimenting here, he does not know. He says he tried ice which helped a little bit, ice always helps, but when it wears out it comes back. He stated he feels the pain walking, when he is putting his shirt on, sitting in his recliner, it is constant. His vaccine card is handwritten, there is no NDC written on there. It has no information about the syringe that was used, NDC/LOT/EXP information were unknown, they didn't put it down or the information on the card for his wallet. Patient stated he saw a doctor but not for the injection site pain. He stated if it was just initial pain, he wouldn't be asking but it has been 10 days now, he thought it would be gone by now, he tried to see how long it could last on the paper they gave and called the number from the paper. He says he had no swelling, it was just really sore, he would like to know if this is normal, if so, he can hang on and tough it out. Treatment was given in response to the events. Outcome of the events Injection site pain, not sleeping, it still hurts, it is very sore by his bicep was not recovered. Outcome of the events sheer exhaustion and is very uncomfortable sitting was unknown.
2 doses of pfizer then covid positive (1/28/21 and 2/18/21)
throat sore; low grade fever; extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Aug2021 14:15 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMINS C; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; ELDERBERRY [SAMBUCUS NIGRA]; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]. Past drug history included: Succynlcholine, reaction(s): "Allergy to Succynlcholine", notes: Past drug event: Succynlcholine; Mivacron, reaction(s): "Allergy to Mivacron", notes: Past drug event: Mivacron; Codeine, reaction(s): "Allergy to Codeine", notes: Past drug event: codeine; Hydrocodone, reaction(s): "Allergy to Hydrocodone", notes: Past drug event: Hydrocodone. Vaccination history included: Bnt162b2 (Dose 1, administration time=03:15 PM,, vaccine location=Left arm), administration date: 13Aug2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 29Aug2021 04:00, outcome "not recovered", described as "throat sore"; PYREXIA (non-serious) with onset 28Aug2021 04:00, outcome "not recovered", described as "low grade fever"; FATIGUE (non-serious) with onset 28Aug2021 04:00, outcome "not recovered", described as "extremely tired". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oropharyngeal pain, pyrexia, fatigue.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Vitamins C, D, B12, Zinc, elderberry multivitamin. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 after the vaccination. Known Allergies: Succynlcholine, mivacron and codeine/hydrocodone  The follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of Oka-Merck PROQUAD (Lot #: N021728, Exp Date:06-FEB-2019) (Lot#: N022972, Exp Date:19-FEB-2019), (Lot#: N029878, Exp Date: 22-APR-2019) or (Lot#: N025929, Exp Date: 18-MAR-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of MERCK STERILE DILUENT (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787 US-009507513-1805USA009900:Original Case : 1805USA006787 US-009507513-1805USA009901:Original Case : 1805USA006787 US-009507513-1805USA009902:Original Case : 1805USA006787 US-009507513-1805USA009903:Original Case : 1805USA006787 US-009507513-1805USA009904:Original Case : 1805USA006787 US-009507513-1805USA009905:Original Case : 1805USA006787 US-009507513-1805USA009906:Original Case : 1805USA006787 US-009507513-1805USA006787:Original Case : 1805USA006787 US-009507513-1805USA009908:Original Case : 1805USA006787 US-009507513-1805USA009909:Original Case : 1805USA006787 US-009507513-1805USA009910:Original Case : 1805USA006787 US-009507513-1805USA009911:Original Case : 1805USA006787 US-009507513-1805USA009912:Original Case : 1805USA006787 US-009507513-1805USA009913:Original Case : 1805USA006787 US-009507513-1805USA009914:Original Case : 1805USA006787 US-009507513-1805USA009915:Original Case : 1805USA006787 US-009507513-1805USA009916:Original Case : 1805USA006787 US-009507513-1805USA009917:Original Case : 1805USA006787 US-009507513-1805USA009918:Original Case : 1805USA006787 US-009507513-1805USA009919:Original Case : 1805USA006787 US-009507513-1805USA009920:Original Case : 1805USA006787 US-009507513-1805USA009921:Original Case : 1805USA006787 US-009507513-1805USA009922:Original Case : 1805USA006787 US-009507513-1805USA009923:Original Case : 1805USA006787 US-009507513-1805USA009924:Original Case : 1805USA006787 US-009507513-1805USA009925:Original Case : 1805USA006787 US-009507513-1805USA009926:Original Case : 1805USA006787 US-009507513-1805USA009927:Original Case : 1805USA006787 US-009507513-1805USA009928:Original Case : 1805USA006787 US-009507513-1805USA009929:Original Case : 1805USA006787 US-009507513-1805USA009930:Original Case : 1805USA006787 US-009507513-1805USA009931:Original Case : 1805USA006787 US-009507513-1805USA009932:Original Case : 1805USA006787 US-009507513-1805USA009933.