chrisvoncsefalvay/vaers-outcomes huggingface dataset:
incredible headache; Vomiting; Dizziness; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; had tingling in his hands and the EMS thought it was from anxiety and his nerves from feeling this way; This is a spontaneous report from a contactable registered nurse. A 16-year-old male patient received second dose of meningococcal group b rlp2086 (TRUMENBA, suspension for injection, NDC number: 005-0100-10, Batch/lot number: AM6864, Expiry Date: Mar2021, strength: 0.5 ml), intramuscularly on 13Aug2019 at 0.5ml single in prefilled syringe given intramuscular in the left deltoid for vaccination to complete his series. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of meningococcal group b rlp2086 for immunization on an unspecified date. On 13Aug2019, the patient experienced incredible headache, vomiting, and dizziness. The patient was in the office for a bit after the shot. The patient drove for about 20 minutes after leaving the office and then had to pull off to the side of the road because he experienced an incredible headache, vomiting, and dizziness. The patient had tingling in his hands and the electronic medical system (EMS) thought it was from anxiety and his nerves from feeling this way, from Aug2019. The outcome of events incredible headache, vomiting and dizziness was resolved on 13Aug2019, and outcome of the other events was unknown. Reporter considered seriousness for events incredible headache, vomiting, dizziness as medically significant.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of events incredible headache, vomiting, dizziness cannot be excluded, assuming a plausible temporal association and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
hips were hurting; having hard time getting up and down;  This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN6201, expiration date: unknown, via an unspecified route of administration in Arm Right on 22Feb2021 11:00 as single dose for covid-19 immunisation. The patient medical history included atrial fibrillation from Jan2020 and ongoing and breast cancer about 8-9 years ago in the left breast. The patient concomitant medication included apixaban 5mg twice a day by mouth taken for atrial fibrillation, diltiazem hydrochloride 180mg once a day by mouth, lisinopril 20mg twice a day by mouth taken for blood pressure measurement and was ongoing, hydralazine 25mg twice a day by mouth taken for blood pressure measurement and all were ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EL3247, expiration date: unknown, via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation and had soreness in her arm for a couple of days. The patient clarified that she had the first dose on 01Feb2021. She said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. On 23Feb2021, after second dose, the patient stated that her hips started hurting around 3 and then they hurt all night and have hurt ever since. She is having a hard time getting up and down. She said that around 14:00-15:00 her hips started hurting and got progressively worse. She said that she kept a hot water bottle on it. She said that it is hard to get up and down, especially off of the toilet. She took a Tylenol at 0900 23Feb2021. She said that she has had no problem with her hip prior to this. Her pain in her hips has improved since she took a Tylenol. She said that she does have a sensitivity to medication. She said that she had no reaction except for soreness from the first shot. Her arm is a little sore now, but it is her hip that is bothering her now. She said that she does not have any artificial hips or anything. She said that she has all of her body parts. Outcome of the event hips were hurting was recovering and having hard time getting up and down was not recovered.
On 03/12/2021 at about 4am I woke up with pain in my right side in the should and back, below right lung area in the back. At 2:3-pm I went to Urgent care and they referred me to the ER-I had a clot, I was given Xarelto and oxy. I am still in recovery, with Xarelto.
Polymorphic annular blanching nonpruritic erythematous nonmigratory macules about the wrists, hands, ankles, axillae, and anteromedial proximal thighs. Fading after 3 days. Similar rash also 7 days after first dose of HPV vaccine.
no adverse effect reported; one dose of improperly stored VARIVAX was administered; Information has been received from a medical assistant referring to a patient with unknown age and gender. The patient's concomitant drug included sterile diluent. The patient's pertinent medical history, drug reactions or allergies were not reported.  On 05-APR-2019, the patient received one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number: R018980; expiration date: 01-JUL-2020; strength was not reported), subcutaneously for prophylaxis. No adverse effect reported. The temperature of storage was 6 degrees Fahrenheit to 14 degrees Fahrenheit (9.7F) for 1 hour and 17 minutes; 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.6 F) for 35 minutes. There was no previous temperature excursion. Data logger was involved.
Pt recvd vax 22JUN92 & shortly following vax devel continual h/a (migraines),numbness & tingling in both arms,nausea,severe low back pain around the areas of both kidneys,photosensitivity,aching in muscles&joints,fatigue,& eyes yellowish
I woke up late Tuesday morning at 4 am with dry extreme scratchiness in my throat and it hurt and was difficult to swallow. It wasn't relieved with drinking fluids. I went back to sleep and got up at 8am and it continued and I didn't feel good. I started feeling like I needed to cough so the next morning i took a home covid test 8 am Wednesday morning and it was positive. I called my doctor and he sent me for the molecular test. I had it done that Wednesday. I never got a fever I got up to 99.5, i was breathless tired but with no headache. Thursday I started coughing, my worst day was Friday and I was lethargic and dry coughing and felt bad. Saturday test came back positive but my cough was looser and by Sunday I started feeling better and Monday i felt confident i was on my way to recovery.
Outbreak of Herpes simplex virus; This case was reported by a nurse via sales rep and described the occurrence of herpes simplex in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2019AMR107844).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced herpes simplex. The patient was treated with acyclovir. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the herpes simplex was unknown.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details were provided as follows: This case was reported by the Nurse (Department Manager). The patient reported an outbreak of herpes simplex after 2nd dose of shingrix. She was put on acyclovir after the break out. The reporter agrees to follow up.
After vaccines was given 3/24/99 he developed chickenpox varicella.  Follow-up received from doctor's office states patient unknown to our practice.
This spontaneous report was received from a licensed practical nurse and refers to a 6-month-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 22-AUG-2016, the patient was vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported) and ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012916.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 71-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date) and SHINGRIX (1st dose received on an unknown date, without any adverse event). On 27th November 2018, the patient received the 2nd dose of SHINGRIX. On 27th November 2018, less than a day after receiving SHINGRIX, the patient experienced chills. On 28th November 2018, the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX on the right arm. The reporter stated that in the evening she had chills. She went to bed and the chills were resolved by the next day of vaccination day. The reporter denied any issues with the first dose of SHINGRIX. The reporter consented to follow up.
Information has been received from a nurse concerning a 42 year old male with allergy to Prozac who received dose 1 of MMR II as a child tested negative for rubella titers. His measles and mumps titers were high. The patient is in nursing school and on 02-JAN-2008 he received a second dose of MMR II (Lot # 655270/1409F). Concomitant therapy included tuberculin purified protein derivative vaccination given during the same visit as the second vaccination of MMR II. On 18-AUG-2008 his rubella titer was still negative. No other details given. Unspecified medical attention was sought. No product quality complaint was involved.
Pfizer-BioNTech Covid-19 vaccine EUA woke up 2/3/21 experiencing fatigue. As the morning progressed developed body aches, chills, slight sore throat, HA and worsening fatigue, remained afebrile.
Information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates in October 2016 (reported as "at the beginning of October 2016"), the patients were vaccinated with doses of improperly stored PROQUAD (lot # L045675 with expiration date 09-MAY-2017; dose and route were unknown), for prophylaxis. The vaccines were exposed under temperature of 14 degrees Fahrenheit for a short amount. The previous temperature excursions started at the beginning of October 2016. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. All telephone attempts to obtain to follow-up information on 05-JAN-2017 have been unsuccessful. Additional information has been requested. Narrative was updated. Sender's Comments: US-009507513-1611USA002911: US-009507513-1611USA000085: MERCK 1611USA002910:Mfr number.
Patient received the Moderna Covid-19 vaccine, lot # 041L20A, exp 07/03.2021, then proceeded to the observation area.  According to the observers, after roughly eight minutes in the observation area, the caregiver started reporting "throat tightness, chest heaviness and a metallic taste in her mouth."  Rapid response was called to the scene.  Patient's BP was 110/70.  No tachycardia with palpation or tachypnea with observation.  Patient was not diaphoretic.  Patient then reported a dull HA.  Patient declined transfer to the ED, stating that she felt much better.   Patient remained in the observation area for a full hour, then walked herself out to meet her husband at the car.
DAY 2, FEVER, CHILLS, ACHES DAY 3 VERTIGO WHILE IN LYING POSITION
Initial misuse report received from a healthcare professional on 12 AUGUST 2013. A patient (no information regarding the patient) was administered dose 1 and dose 1 of post exposure series of IMOVAX rabies at gluteal region and dose 2 was administered at deltoid region. No adverse event was reported. Documents held by sender: none
pt recv vax 29OCT97 & 30min p/vax pt exp generalized hives w/o any other sx;tx consisted of DPH given @ MD office;
This spontaneous report as received from a medical assistant refers to a patient (demographic data not provided). On 16-MAY-2014, the patient was vaccinated improperly stored dose of RECOMBIVAX HB (thimerosal status: not provided) (lot #, expiration date: unspecified). No adverse events were reported. Additional information has been requested.
After vaccination, the patient's arm was sore. On 1/29/21 she noticed in the mirror that the left arm at the injection site was red and swollen. Patient was advised to use an ice compress to help with the swelling.
Pt had pruritis and redness of upper right extremity. Pt also experienced itchiness in the area.
Seen in office 6/26/07 with R arm swelling induration and warm at Menactra and PPV 23 injection sites (given on 6/25/07) Afebrile, c/o pain in L arm. MD instructed ice area, Motrin, Benadryl to call increased redness, swelling, fever.
I got the J&J one shot and 12 hours later took myself to ER when BP hit 180/96. It went down in about 4 hours  to 150/83 without treatment and all blood work etc was normal range. I was dismissed. My BP is normally in the 120-130/80 range and has since returned to this.  I report this because I saw a comment in the newspaper by someone who said their 86 year old father had a HI BP episode after the shot that landed him in hospital and required treatment. That's two then, so I thought it best to report it in case there are more.
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (my arm was sore at the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (my arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (my arm was sore at the injection site) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment included Aleve for body aches. This case was linked to MOD-2021-402852, MOD-2021-402823 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow-up contact info update, reporter added-HCP, lot number information for dose2.
It was reported that a 44 year old female received Fluzone SV '99-'00 on 10/9/99 and experienced "extreme sleepiness, 4 hours, post vax". No further information is available at this time.
devel redness & pain @ inj site w/swelling w/1st 24hrs then devel muscle & joint pain (arms & legs) in 48hrs past inj;hobbling when walks;
Patient died from a ruptured aortic dissection that caused a hemopericardium with tamponade
Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48-year-old female patient received BNT162b2 (BNT162B2), on 24Jul2021 as dose 1, single (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 46 years and on 22Dec2021 as dose 2, single (Lot number: FL3197, Expiration Date: Jun2022) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine". The patient underwent the following laboratory tests and procedures: Electrocardiogram: Results unknown, notes: EKG because all I can get help because all I have is the health problem."; SARS-CoV-2 test: Positive, notes: Because I got Covid twice between them. I had Covid at least three time since I had the Vaccine.  Clinical Information: Patient had never been diagnosed with diabetes. Patient did not take regular medication. Patient did not take anything daily. Patient got one at the hospital and one at (withheld). Because got Covid twice between them. Patient had Covid at least three time since the Vaccine. So, it do not stop Covid. Patient reported that he did not take any vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201313252 same reporter, different event;
Patient had moderate to severe arm pain, swelling within hours of vaccination, sending her to ER due to pain and swelling. Very warm/hot tight skin per patient.
9 days after the injection i noticed the injection site was very red and swollen-- the area was about 1 square inch.  It did not itch or hurt and slowly disappeared over the next 5 days.
TOOK LAST DOSE OF VIVOTIF THAT WAS FROZEN; A spontaneous case report was received from a consumer on 24-Oct-2019 for two consumers.   Based on the information obtained from the consumer two individual case safety report PVX201910-000818 (PVX2019-2655; husband) and PVX201910-000819 (PVX2019-2658; wife) were created and cross-linked in the database.   This case (PVX2019-2658) described a female consumer who "took last dose of Vivotif that was frozen" (PT: Product storage error), while being on Vivotif capsule for typhoid prophylaxis.  Case report: The consumer took three doses of Vivotif. Then, on 18-Oct-2019, she took last dose that was frozen.  Action taken with Vivotif with respect to the event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took last dose of Vivotif that was frozen" was considered as not applicable. US-PVX201910-000818:
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: patient diagnosed with cellulitis, cephalexin was dispensed
Positive covid test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive covid test after 1st dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive covid test after 1st dose). At the time of the report, COVID-19 (Positive covid test after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported  No Treatment information was reported
1st injection (2/26): no symptoms 2nd injection (3/19):  24 hours after = headache, lethargic, achy, 100+ fever (lasted about 8-10 hours).  30 hours after = pink rash began to form all around upper arm. became darker pink the following day.  currently still have rash 3 full days after 2nd injection.
Runny nose; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (Runny nose) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient completed his 3 doses of Moderna COVID vaccine as well around June or July.  No relevant concomitant medications were reported. No treatment information was provided.
pain redness and swelling at the injection site; pain redness and swelling at the injection site; pain redness and swelling at the injection site; A rash on the injection sight arm; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "pain redness and swelling at the injection site"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "A rash on the injection sight arm". Therapeutic measures were taken as a result of vaccination site rash. Additional information: the 66-year-old female patient who was the mother of the reporter received PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and had pain, redness, and swelling at the injection site. The patient experienced a rash on the injection sight arm five days after receiving the vaccine. The patient reported the rash lasted for two days and was resolved after taking diphenhydramine hydrochloride (BENADRYL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/15, 5 days after patient received the vaccines she experienced excruciating pain in her left arm. She was unable to lift or turn (the motion to put on a seatbelt was very painful). She also experienced numbness in her pinky and ring finger of her left arm. Pain had not resolved on through 11/21. 11/22 patient's arm is able to lift and able to motion to put a seatbelt on.