chrisvoncsefalvay/vaers-outcomes huggingface dataset:
not feeling well; headache a pain in her left head; Body Aches; Pain in left arm; Neck Ache on Left Side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Anatomical Location of Administration: Right Arm, Outcome of reaction: Recovered/Resolved), administration date: 28Mar2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Flu Like Symptoms", "Fever", "Body Aches". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not feeling well"; HEADACHE (non-serious) with onset 20Apr2021, outcome "not recovered", described as "headache a pain in her left head"; PAIN (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Body Aches"; PAIN IN EXTREMITY (non-serious) with onset 20Apr2021, outcome "recovered" (2021), described as "Pain in left arm"; NECK PAIN (non-serious) with onset 20Apr2021, outcome "unknown", described as "Neck Ache on Left Side". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain, pain in extremity, neck pain.  Additional Information : Patient clarified after the first dose of the vaccine, she had flu like symptoms of fever and body aches that lasted for 3-4 days, exact dates unknown. Patient stated after the second dose of the Covid vaccine she had aches in her body and a headache on the left side and her neck and had pain in her arm for 2-3 days. Exact dates are unknown. Patient stated she hasn't gotten the flu for about 10 years. States she never gets sick. Treatment: Amoxicillin and Ibuprofen  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
her eyes were having flashes of bright and fast/ rescue truck having the red lights on and they would be flashing really Both eyes; booster shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 84 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 2, manufacturer unknown), administration date: 2021, for Covid-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), administration date: 2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster shots"; PHOTOPSIA (non-serious) with onset 11Dec2021, outcome "unknown", described as "her eyes were having flashes of bright and fast/ rescue truck having the red lights on and they would be flashing really Both eyes".  The lot number for bnt162b2 was not provided and will be requested during follow up.
swelling; right leg wouldn't move from the knee to the foot/I couldn't move my legs, like they were tightened together; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and DYSKINESIA (right leg wouldn't move from the knee to the foot/I couldn't move my legs, like they were tightened together) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced SWELLING (swelling) and DYSKINESIA (right leg wouldn't move from the knee to the foot/I couldn't move my legs, like they were tightened together). At the time of the report, SWELLING (swelling) outcome was unknown and DYSKINESIA (right leg wouldn't move from the knee to the foot/I couldn't move my legs, like they were tightened together) had resolved. Not Provided          No relevant concomitant medications were reported. Treatment details included Not provided.
Information has been received from a medical assistant concerning a 15 year old female with no pertinent medical history who on 15-AUG-2007 was vaccinated intramuscularly with a 0.5ml first dose of Gardasil (Lot # 658490/0802U).  There was no concomitant medication.  On 15-AUG-2007 the patient experienced shaking and became rigid and blacked out.  Unspecified medical attention was sought.  There was no laboratory or diagnostic tests performed.  On 15-AUG-2007 the patient recovered.  Additional information has been requested.
This case was reported by a other health professional via sales rep and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced chills, stomach pain, headache, light headedness, tiredness and nerve pain. On an unknown date, the outcome of the chills, stomach pain, headache, light headedness, tiredness and nerve pain were recovered/resolved. It was unknown if the reporter considered the chills, stomach pain, headache, light headedness, tiredness and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. History was the patient's mom was sure her brother, sister and did not get chicken pots as kiddos, she had us go to too many chicken pox parties and she said they never got them. Within hours the patient had a stomachache, headache, light headed and had the chills. The next day same symptoms but also was very tired and had shooting pains in some of her nerves. All in all lasted about 48 hours. On a scale from one to ten, the patient was feeling like a six or seven we also almost did not go camping because I was concerned if I got worse there was no medical establishment within an hour and a half from where we were camping. But, by day three the patient was almost 100 percentage recovered. This case has been linked with US2018GSK107279, reported by the same reporter.
Severe tinnitus starting in left ear then 1 week later the tinnitus is in both ears. Very loud, low, roar causing vertigo, nausea and hearing loss. Horrific headaches.
17year old patient received the vaccine in the left arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17year old patient received the vaccine in the left arm) 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.   This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 003A21A) with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 003A21A) with no associated AEs.
2  days if exhaustion; Headache; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. On an unknown date, the patient experienced 2 days if exhaustion and headache. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event 2 days if exhaustion and headache was recovered on unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
From initial information received on 24Feb05 from the pt regarding an adverse event occurring it was reported that the female pt received a dose of diphtheria and tetanus toxoids, a dose of typhoid vaccine (manf not reported) and dose of YF VAX on 15Feb05. The lot numbers and routes of admin were not reported. The diphtheria and tetanus toxoids was administered .5 inches from the shoulder joint. Four days later, on 19Feb05, the pt experienced pain in the shoulder joint and muscle aches with limited mobility. SHe also complained of nausea and chest congestion. Her physician prescribed ibuprofen 800mg and ordered an MRI. The pt was advised to see an orthopedic specialist. She continues to have persistent pain in the shoulder joint area and has not recovered.
blood pressure continues to rise; numbness; feels the need to vomit; This spontaneous case was reported by a patient and describes the occurrence of HYPERTENSION (blood pressure continues to rise), HYPOAESTHESIA (numbness) and VOMITING (feels the need to vomit) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknonw) 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 HYPERTENSION (blood pressure continues to rise), HYPOAESTHESIA (numbness) and VOMITING (feels the need to vomit). At the time of the report, HYPERTENSION (blood pressure continues to rise), HYPOAESTHESIA (numbness) and VOMITING (feels the need to vomit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that his blood pressure was continuing to rise all day, numbness, and felt like vomiting. No concomitant medications were reported.  No treatment information was reported.
hot spot; (rash) came back/rash in left arm; red spot; itchiness extended pretty much to my upper arm, almost until the elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot spot), VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), LEVOTHYROXINE, LORATADINE (CLARITIN [LORATADINE]) and COLECALCIFEROL (VITAMIN D3 1000) for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow). On an unknown date, the patient experienced VACCINATION SITE WARMTH (hot spot), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at a dose of once or twice. At the time of the report, VACCINATION SITE WARMTH (hot spot) outcome was unknown and VACCINATION SITE PRURITUS (itchiness extended pretty much to my upper arm, almost until the elbow), VACCINATION SITE RASH ((rash) came back/rash in left arm) and VACCINATION SITE ERYTHEMA (red spot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient said that the rash lasted for 3-4 days,but then it came back. It lasted around 12 days at the most. Patient said that cold compresses worked the best. Patient takes Omega 3 1280 mg twice a day.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up received contains significant information: updated event - hot spot, Event onset day, Concomitant medication, treatment medication, expiration date of 1st dose, second dose information, email, address information updated.
Large swelling (about the size of a half baseball)  Large Red area Hot to the touch  Pain
The patient is stating that she is having muscle and joint pain secondary to the PREVNAR 13 immunization given on 02/23/2018. She states that her shoulder is still sore, and she is having difficulty standing and moving around. The patient also shared that she suffers from Diabate Mellitus 2, COPD, osteoporosis, and weighs close to 400 lbs. She attributes the decline in mobility to the PREVNAR 13 injection.
This spontaneous report was received from the patient's girlfriend concerning her boyfriend of unknown age. The patient's pertinent medical history, drug allergies/drug reactions were not reported. On 23-JAN-2018, the patient was vaccinated with a third dose (final dose) of hepatitis B vaccine (recombinant) (manufacturer unknown) (dose, Lot #, expiration date and therapy type not reported) for prophylaxis. Concomitant vaccine given on the same day included influenza virus vaccine (unspecified) and paroxetine hydrochloride (PAXIL) which started that evening of 23-JAN-2018.     The patient's girlfriend reported that on 25-JAN-2018, reported as yesterday, he complained of increased urination overnight and slight nausea, and on 26-JAN-2018, reported as this afternoon, he complained of severe tension/pain in his shoulders.   The outcome of nocturia, muscle tightness, musculoskeletal pain and nausea was unknown.        The causal relationship between the events and hepatitis b vaccine (recombinant) (manufacturer unknown) was not reported.
Pt is complaining of right arm pain since vaccine. Pt states she has come in a few times to speak to the pharmacist who gave it to her but she was not here. She says her arm hurts to move it backward. Has been to her MD who recommended Physical therapy.
No additional AE; 5 day old infant was inadvertently administered ROTATEQ; This spontaneous report was received from a medical assistant referring to a 5-day-old patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not provided.  On 02-FEB-2022, the 5-day-old patient was inadvertently administered a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product administered to patient of inappropriate age) 2 milliliter (lot number U006175, expiration date 02-SEP-2022; vaccination scheme, route of administration, and anatomical location of vaccination were not reported), for prophylaxis.  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) was reported.
1 day p/vax pt devel swelling, a 3 inch area of redness & a lump @ the site of vax;pt recovered;this is 1 of 4 pt from this site to devel an inj site rxn p/vax;
This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, lot number was M024702 and expiration date of 18-MAY-2018 (strength, route of administration and dose were not reported). There were no concomitant therapies nor adverse effect reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Fevers persisted initially for approx. 2 weeks and now fevers and chills come and go every other day to two days. Patient has had neck pain onset of vaccination day as well since the IM shot.
This case was reported by a healthcare professional via a sales representative and described the occurrence of hive in a 8-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  There were no concurrent medications.  On 27 June 2008 at 17:00 the subject received 2nd dose of HAVRIX at 0.5 ml (720 elisa units) in the left arm.  On 27 June 2008, sometime after 19:00, the subject started to develop hives all over his body (a systemic reaction).  He was seen in the office the following day.  The hives were 1/2 mm in size.  The subject was treated with BENADRYL.  The subject had previously received HAVRIX without any problems.  At the time of reporting the hives were resolved.  The healthcare professional considered that the event was probably related to vaccination with HAVRIX.  The reporter stated that they did not want to use any of the remaining doses of HAVRIX from the same lot as the 2nd dose.  This was considered to be a product complaint.
Each patient received dose of Moderna vaccine post excursion; Each patient received dose of Moderna vaccine post excursion; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Each patient received dose of Moderna vaccine post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Each patient received dose of Moderna vaccine post excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Each patient received dose of Moderna vaccine post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Each patient received dose of Moderna vaccine post excursion).    No concomitant medications were reported.  This case contains information for the 12th of 19 patients reported by the reporter.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-706941 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-706941:Pt 1 of 19 (master case)
Information has been received from a healthcare worker referring to an unspecified number of children of unknown age and gender. On unknown dates, the children were vaccinated with improperly stored doses of M-M-R II (Lot number K015374 with expiration date 18-SEP-2016; Lot number K018965 with expiration date 15-OCT-2016; Lot number L003855 with expiration date 05-FEB-2017; reported lot number L007578 withe expiration date 05-MAR-2017, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the reporter did not want to be contacted.
Pfizer Covid-19 5-11 yo vial was not diluted prior to vaccine administration. Patient received incorrect dosing per recommendation. Provider on site aware.
Got booster on 12/20/2021. 12/26/2021: cut trees down; cleaned barn all day long. Right arm got tired so started using left arm. 12/27/2021: woke up both arms so sore could hardly move. 12/28/2021: right arm was fine. Left arm weakness persisted and never got better. Bicep is weak He used to put all medicine in left hand and put it in mouth. Now he cannot lift left hand to the mouth (doing a bicep curl). No numbness/tingling in left arm. Left shoulder occasionally feels numbness. 2/28/2022 symptoms of bicep weakness still present along with posterior shoulder numbness.
Per patient: All symptoms started about 2:30am on Friday morning waking patient up. Swelling was first (with fever in injected arm) with "deep pain" and chils to follow. All symptoms lasted all day Friday (12/4/2015). Patient went to ER Friday at ~11pm. Patient feels "75%" better as of Saturday 12/5/2015 @ 3:30.
Dizziness; fast heart beat; difficulty breathing; affecting me a lot already; muscle pain; headache; nausea; fatigue; Tendernesss in my right arm; A spontaneous report was received from a healthcare professional concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting lot already, lot of difficulty breathing.  The patient's medical history was not provided. Concomitant medications reported were Theophylline, Symbicort inhaler, salbutamol sulfate for drug use for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting me a lot already, lot of difficulty breathing.  Treatment details included Aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tenderness in right arm, dizziness, fast heart beat, difficulty breathing, muscle pain, fever, headache, nausea, fatigue, affecting  lot already, lot of difficulty breathing was unknown.
Blisters on the hands, feet, and inside mouth.  Doctor said they are seeing this in some people with the 2nd Pfizer shot.  Told us it should disappear in 10 days maximum.
Patient reported nausea, and felt lightheaded.  Vitals BP 110/82, Pulse 62, O2 99%.  Monitored additional 15 minutes symptoms were gone.  Stated he felt better and was cleared.
Body aches, nausea, fever 100.1-99.5, headache, tight achy chest